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

Products, Red-Cell Lysing Products

21 CFR 864.8540 / Hematology
FDA source (opens on fda.gov)

GGK is the FDA product code for Products, Red-Cell Lysing Products, a class I device type, regulated under 21 CFR 864.8540. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
GGK
Device name
Products, Red-Cell Lysing Products
Regulation
21 CFR 864.8540
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
29
Ingested recalls
7

Clearances, product code GGK

By decision year
29 clearances under product code GGK with a decision year between 1976 and 1988, 1984 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code GGK by decision year
YearClearances
19761
19771
19781
19792
19801
19811
19823
19833
19848
19852
19862
19872
19882

Applicants with the most clearances

Product code GGK
Applicants holding the most 510(k) clearances under product code GGK
ApplicantClearances
E K Ind., Inc.4
Connecticut Diagnostics, Ltd.2
Hematology Marketing Assoc.2
Reagent Laboratory, Inc.2
Abbott Diagnostics1
Central Labs. Assoc. MD Pathologists1
Coulter Immunology1
Dade, Baxter Travenol Diagnostics, Inc.1
Electrophoresis Corp. of America1
Fisher Scientific Company L.L.C.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order