510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MSJClass I

Apolipoproteins

21 CFR 862.1475 / Clinical Chemistry
FDA source (opens on fda.gov)

MSJ is the FDA product code for Apolipoproteins, a class I device type, regulated under 21 CFR 862.1475. As of , FDA records hold 50 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MSJ
Device name
Apolipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
50
Ingested recalls
0

Clearances, product code MSJ

By decision year
50 clearances under product code MSJ with a decision year between 1983 and 2008, 1987 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code MSJ by decision year
YearClearances
19831
19841
19856
19866
19878
19887
19893
19914
19926
19931
19972
20001
20072
20082

Applicants with the most clearances

Product code MSJ
Applicants holding the most 510(k) clearances under product code MSJ
ApplicantClearances
Atlantic Antibodies4
Beckman Instruments, Inc.4
Bacton Assay Systems, Inc.2
Instrumentation Laboratory Co.2
Intl. Diagnostic Laboratories, Ltd.2
Kallestad Diag, A Div. of Erbamont, Inc.2
Kent Laboratories, Inc.2
Medical Analysis Systems, Inc.2
Northwest Biotech2
Orion Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order