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

Calibrator, Surrogate

21 CFR 862.1150 / Clinical Chemistry
FDA source (opens on fda.gov)

JIW is the FDA product code for Calibrator, Surrogate, a class II device type, regulated under 21 CFR 862.1150. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JIW
Device name
Calibrator, Surrogate
Regulation
21 CFR 862.1150
Device class
Class II
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
17
Ingested recalls
0

Clearances, product code JIW

By decision year
17 clearances under product code JIW with a decision year between 1979 and 1997, 1988 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JIW by decision year
YearClearances
19791
19802
19811
19853
19884
19891
19902
19911
19972

Applicants with the most clearances

Product code JIW
Applicants holding the most 510(k) clearances under product code JIW
ApplicantClearances
Union Carbide Corp.2
American Research Products Co.1
Analytical Control Systems1
Boehringer Mannheim Corp.1
Dade Chemistry Systems, Inc.1
Siemens Healthcare Diagnostics Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Flow Cytometry Standards Corp.1
Hyland Therapeutic Div., Travenol Laboratories1
King Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code