Cleared Traditional

K790015 - SERUM

K790015 is the FDA 510(k) clearance for SERUM by Fisher Scientific Co., LLC. It is a Class 2 Chemistry device (product code JHS) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K790015 · Fisher Scientific Co., LLC · Chemistry device
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Feb 1979
Decision
43d
Days
Class 2
Risk

K790015 is an FDA 510(k) clearance for the SERUM, CREATININE PHOSPHOKINASE. Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on February 15, 1979 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K790015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1979
Decision Date February 15, 1979
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

All 20
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K790015.
ESKLAB REAGENT TABLETS
K790918 · Smithkline Diagnostics, Inc. · Jun 1979
DATA-ZYME CK CALORIMETRIC/UV PROCEDURE
K790343 · Data Medical Associates, Inc. · May 1979
ACA CREATINE KINASE ISOENZYMES
K790088 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1979
L-CYSTEINE HYDROCHLORIDE
K781690 · Fisher Scientific Co., LLC · Oct 1978
STAT ULTRA VIOLET LIQUID
K781432 · Beckman Instruments, Inc. · Oct 1978