510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KRYClass II

Calibrator For Platelet Counting

21 CFR 864.8175 / Hematology
FDA source (opens on fda.gov)

KRY is the FDA product code for Calibrator For Platelet Counting, a class II device type, regulated under 21 CFR 864.8175. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KRY
Device name
Calibrator For Platelet Counting
Regulation
21 CFR 864.8175
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code KRY

By decision year
8 clearances under product code KRY with a decision year between 1978 and 1987, 1978 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KRY by decision year
YearClearances
19783
19821
19841
19852
19871

Applicants with the most clearances

Product code KRY
Applicants holding the most 510(k) clearances under product code KRY
ApplicantClearances
Coulter Electronics, Inc.3
Streck Laboratories, Inc.2
Immunogenetics1
R & D Systems, Inc.1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code