FDA product code GIF: Diluent, Blood Cell
GIF is the FDA product code for diluent, blood cell. It is a Class I device, regulated under 21 CFR 864.8200 and reviewed by the Hematology panel. FDA has cleared 38 510(k) submissions under GIF, from 28 different applicants. The average 510(k) review took 46 days (median 40). FDA has posted 13 recalls for GIF devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Diluent, Blood Cell |
| Device class | Class I |
| Regulation | 21 CFR 864.8200 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GIF clearance
Top GIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Distributors, Inc. | 4 | 1985-07-05 |
| Hematology Marketing Assoc. | 3 | 1985-07-30 |
| Kvm Technologies, Inc. | 2 | 1988-10-12 |
| Toa Medical Electronics USA, Inc. | 2 | 1988-07-12 |
| Abbott Diagnostics | 2 | 1988-03-31 |
23 more applicants have GIF clearances. See the full list in Caduvo.
Most recent GIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883990 | Kvm Technologies, Inc. | KVM ISOTONIC DILUENT | 1988-10-12 | 22 |
| K883989 | Kvm Technologies, Inc. | KVM ISOTONIC FLUSH SOLUTION | 1988-10-12 | 22 |
| K882490 | R&D Systems, Inc. | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT | 1988-07-25 | 39 |
| K882267 | Toa Medical Electronics USA, Inc. | SYSMEX QUICKLYSER-II (QLS-200A) | 1988-07-12 | 42 |
| K881130 | Abbott Diagnostics | CELL-DYN ISOTONIC DILUENT | 1988-03-31 | 15 |
Recalls for GIF devices
13 product recalls in 11 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-10.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code GIF?
GIF is the FDA product code for diluent, blood cell. It is a Class I device, regulated under 21 CFR 864.8200 and reviewed by the Hematology panel.
What device class is GIF?
Class I, regulation 21 CFR 864.8200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GIF?
Across 38 cleared submissions the average was 46 days from receipt to decision (median 40).
Which companies have the most GIF clearances?
Scientific Distributors, Inc. (4); Hematology Marketing Assoc. (3); Kvm Technologies, Inc. (2); Toa Medical Electronics USA, Inc. (2); Abbott Diagnostics (2).
Have GIF devices been recalled?
Yes: 13 product recalls across 11 recall events; the most recent began 2025-11-10.
Next steps
- Run an FDA pathway report with predicate devices for product code GIF
- Run a recall and safety report across every GIF manufacturer
- Watch product code GIF 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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