FDA product code GGK: Products, Red-Cell Lysing Products
GGK is the FDA product code for products, red-cell lysing products. It is a Class I device, regulated under 21 CFR 864.8540 and reviewed by the Hematology panel. FDA has cleared 29 510(k) submissions under GGK, from 23 different applicants. The average 510(k) review took 43 days (median 40). FDA has posted 7 recalls for GGK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Products, Red-Cell Lysing Products |
| Device class | Class I |
| Regulation | 21 CFR 864.8540 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GGK clearance
Top GGK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 4 | 1984-09-14 |
| Reagent Laboratory, Inc. | 2 | 1986-10-03 |
| Hematology Marketing Assoc. | 2 | 1985-03-29 |
| Connecticut Diagnostics, Ltd. | 2 | 1982-09-17 |
| Coulter Immunology | 1 | 1988-11-30 |
18 more applicants have GGK clearances. See the full list in Caduvo.
Most recent GGK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883836 | Coulter Immunology | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II | 1988-11-30 | 79 |
| K883991 | Kvm Technologies, Inc. | KVM HEMOGLOBIN LYSING REAGENT | 1988-10-12 | 22 |
| K874054 | Fisher Scientific Co., LLC | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | 1987-10-20 | 15 |
| K873348 | Abbott Diagnostics | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | 1987-09-09 | 20 |
| K863114 | J. D. Assoc. | PIASTRINIT | 1986-11-06 | 85 |
Recalls for GGK devices
7 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code GGK?
GGK is the FDA product code for products, red-cell lysing products. It is a Class I device, regulated under 21 CFR 864.8540 and reviewed by the Hematology panel.
What device class is GGK?
Class I, regulation 21 CFR 864.8540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGK?
Across 29 cleared submissions the average was 43 days from receipt to decision (median 40).
Which companies have the most GGK clearances?
E K Ind., Inc. (4); Reagent Laboratory, Inc. (2); Hematology Marketing Assoc. (2); Connecticut Diagnostics, Ltd. (2); Coulter Immunology (1).
Have GGK devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code GGK
- Run a recall and safety report across every GGK manufacturer
- Watch product code GGK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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