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
GIFClass I

Diluent, Blood Cell

21 CFR 864.8200 / Hematology
FDA source (opens on fda.gov)

GIF is the FDA product code for Diluent, Blood Cell, a class I device type, regulated under 21 CFR 864.8200. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
GIF
Device name
Diluent, Blood Cell
Regulation
21 CFR 864.8200
Device class
Class I
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
38
Ingested recalls
13

Clearances, product code GIF

By decision year
38 clearances under product code GIF with a decision year between 1976 and 1988, 1984 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code GIF by decision year
YearClearances
19762
19771
19782
19792
19803
19811
19823
19834
19848
19856
19871
19885

Applicants with the most clearances

Product code GIF
Applicants holding the most 510(k) clearances under product code GIF
ApplicantClearances
Scientific Distributors, Inc.4
Hematology Marketing Assoc.3
Abbott Diagnostics2
Harleco2
Kvm Technologies, Inc.2
Nobel Scientific Industries, Inc.2
Toa Medical Electronics USA, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Connecticut Diagnostics, Ltd.1
Coulter Electronics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 47 companies shown, in name order