Cleared Traditional

K781609 - ALKALINE PHOSPHATASE IN SERUM

K781609 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE IN SERUM, manufactured by Fisher Scientific Co., LLC. The device is a Class 2 Hematology device with product code CJE cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K781609 · Fisher Scientific Co., LLC · Hematology device
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Oct 1978
Decision
35d
Days
Class 2
Risk

K781609 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE IN SERUM. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1050 - the FDA hematology device 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 Fisher Scientific Co., LLC devices

FDA 510(k) Submission Details - K781609

510(k) Number K781609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1978
Decision Date October 24, 1978
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 113d · This submission: 35d
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 Hematology 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 K781609.
ELVI ALKALINE PHOSPHATATASE
K792413 · Volu Sol Medical Industries · Dec 1979
ALKALINE PHOSPHATASE
K790065 · Macomb Chemical Co. · Feb 1979
ALP REAGENT SET, ALKALINE PHOSPHATASE
K781718 · Medical Analysis Systems, Inc. · Nov 1978
MITROPHENYL, ALKALINE PHOSPHATES
K781472 · Beckman Instruments, Inc. · Sep 1978
ULTRAZYME PLUS ALP
K780095 · Harleco · Feb 1978
ALP REAGENT SET
K780068 · Medical Analysis Systems, Inc. · Feb 1978