Cleared Traditional

K821471 - ULTRAZYME PLUS ALP #64962

K821471 is the FDA 510(k) clearance for ULTRAZYME PLUS ALP #64962 by Emd Chemicals, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K821471 · Emd Chemicals, Inc. · Chemistry device

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Jun 1982

Decision

15d

Days

Class 2

Risk

K821471 is an FDA 510(k) clearance for the ULTRAZYME PLUS ALP #64962,65029&65030. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emd Chemicals, Inc. devices

Submission Details

510(k) Number	K821471 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 18, 1982
Decision Date	June 02, 1982
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

73d faster than avg

Panel avg: 88d · This submission: 15d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1050

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 83

Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K821471.

PARAMAX ALKALINE PHOSPHATASE REAGENT-

K831480 · American Dade · Jun 1983

DATA-ZYME ALKALINE PHOSPHATASE PROCED

K831360 · Data Medical Associates, Inc. · Jun 1983

DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI

K823213 · Boehringer Mannheim Corp. · Nov 1982

GILCHEM ALP REAGENT

K812912 · Gilford Diagnostics · Nov 1981

ULTRA ZYME PLUS ALP #64962, 65029 & 30

K812596 · Harleco · Sep 1981

ALKALINE PHOSPHATASE

K812452 · Pointe Scientific, Inc., · Sep 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K821471

Emd Chemicals, Inc.

Mchenry, IL · US

Regulatory profile

62 submissions 62 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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