FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

LIPID CONTROL SERUM

K Number: K872376 · Decision Aug 5, 1987
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
2
Review Days
47

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Basic Information

Device Name
LIPID CONTROL SERUM
K Number
K872376
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.1660
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Biological Industries
Date Received
June 19, 1987
Decision Date
August 5, 1987
Product Code
JJY
Advisory Committee
Clinical Chemistry
Review Advisory Committee
CH
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JJY Multi-Analyte Controls, All Kinds (Assayed)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (JJY), ordered by most recent decision date.

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Other Clearances by Biological Industries

K Number Device Name
K871788 LIQUID TDM CONTROLS