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

Nephelometer

21 CFR 866.4540 / Immunology
FDA source (opens on fda.gov)

JZW is the FDA product code for Nephelometer, a class I device type, regulated under 21 CFR 866.4540. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JZW
Device name
Nephelometer
Regulation
21 CFR 866.4540
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
1

Clearances, product code JZW

By decision year
11 clearances under product code JZW with a decision year between 1976 and 2000, 1976 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JZW by decision year
YearClearances
19762
19781
19791
19802
19872
19891
19901
20001

Applicants with the most clearances

Product code JZW
Applicants holding the most 510(k) clearances under product code JZW
ApplicantClearances
Behring Diagnostics, Inc.4
B C Medical, Ltd.1
Beckman Instruments, Inc.1
Siemens Healthcare Diagnostics Inc.1
Incstar Corp.1
Sherwood Medical Industries1
Travenol Laboratories, S.A.1
Unipath, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code