Cleared Traditional

K791118 - HLA CONTROL SERA

K791118 is an FDA 510(k) clearance for HLA CONTROL SERA, manufactured by Calbiochem-Behring Corp.. The device is a Class 1 Hematology device with product code LGO cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K791118 · Calbiochem-Behring Corp. · Hematology device
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Aug 1979
Decision
49d
Days
Class 1
Risk

K791118 is an FDA 510(k) clearance for the HLA CONTROL SERA. Classified as Test, Leukocyte Typing (product code LGO), Class I - General Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7675 - 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.

FDA 510(k) Submission Details - K791118

510(k) Number K791118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1979
Decision Date August 03, 1979
Days to Decision 49 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
64d faster than avg
Panel avg: 113d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

LGO Device Classification - Class 1, General Controls

Product Code LGO Test, Leukocyte Typing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7675
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 - LGO Test, Leukocyte Typing

Devices cleared under the same product code (LGO) and FDA review panel - the closest regulatory comparables to K791118.
PLATELIA TOXO IGG KIT
K894947 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
K874544 · Molecular Biosystems, Inc. · Aug 1988
LYMPHOCYTE TYPING, NEGATIVE CONTROL
K761008 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1977
LYMPHOCYTE TYPING, POSITIVE CONTROL
K761009 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1977
K791118 · HLA CONTROL SERA
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