Cleared Traditional

K832463 - RAICHEM ALKALINE PHOSPHATASE REAGENT

K832463 is an FDA 510(k) clearance for RAICHEM ALKALINE PHOSPHATASE REAGENT, manufactured by Reagents Applications, Inc.. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K832463 · Reagents Applications, Inc. · Chemistry device
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Sep 1983
Decision
48d
Days
Class 2
Risk

K832463 is an FDA 510(k) clearance for the RAICHEM ALKALINE PHOSPHATASE REAGENT. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 48 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 Reagents Applications, Inc. devices

FDA 510(k) Submission Details - K832463

510(k) Number K832463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date September 12, 1983
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

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 115
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K832463.
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918 · Sigma Diagnostics, Inc. · Jun 1984
KINETIC ALKALINE PHOSPHATASE
K834033 · American Monitor Corp. · Jan 1984
ALKALINE PHOSPHATASE-RATE
K833744 · Seragen Diagnostics, Inc. · Jan 1984
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