Cleared Traditional

K780563 - SINGLE VIAL LACTATE

K780563 is an FDA 510(k) clearance for SINGLE VIAL LACTATE, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Hematology device with product code CFJ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K780563 · Boehringer Mannheim Corp. · Hematology device
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Apr 1978
Decision
11d
Days
Class 2
Risk

K780563 is an FDA 510(k) clearance for the SINGLE VIAL LACTATE. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1978 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1440 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K780563

510(k) Number K780563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1978
Decision Date April 18, 1978
Days to Decision 11 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
102d faster than avg
Panel avg: 113d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFJ Device Classification - Class 2, Special Controls

Product Code CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
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 - CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

All 87
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K780563.
LDH
K781775 · Gilford Diagnostics · Nov 1978
NAD REDUCTION METHOD, LACTATE PYRIVATE
K781724 · Medical Analysis Systems, Inc. · Nov 1978
SINGLE VIAL LDH-L TRIS
K781538 · Boehringer Mannheim Corp. · Oct 1978
ULTRAZYME PLUS LDH
K780101 · Harleco · Feb 1978
LACTATE DEHYDROGENASE
K780041 · Beckman Instruments, Inc. · Feb 1978
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
K772028 · Harleco · Nov 1977