Cleared Traditional

K780042 - HYDORRYBUTYRATE DEHYDROGENASE

K780042 is an FDA 510(k) clearance for HYDORRYBUTYRATE DEHYDROGENASE, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JMK cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K780042 · Beckman Instruments, Inc. · Chemistry device
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Feb 1978
Decision
23d
Days
Class 1
Risk

K780042 is an FDA 510(k) clearance for the HYDORRYBUTYRATE DEHYDROGENASE. Classified as Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase (product code JMK), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1978 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1380 - 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K780042

510(k) Number K780042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1978
Decision Date February 01, 1978
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

JMK Device Classification - Class 1, General Controls

Product Code JMK Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JMK Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase

All 13
Devices cleared under the same product code (JMK) and FDA review panel - the closest regulatory comparables to K780042.
HBDH ENZYME KINETIC REAGENT SET
K781720 · Medical Analysis Systems, Inc. · Nov 1978
HBDH REAGENT SET
K780073 · Medical Analysis Systems, Inc. · Feb 1978
ULTRAZYME PLUS HBD
K780104 · Harleco · Feb 1978
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
K772033 · Harleco · Nov 1977
MULTISTAT III X-HBDH TEST
K771474 · Instrumentation Laboratory CO · Sep 1977
ULTRAZYME PLUS HBD
K770871 · Harleco · Jul 1977