FDA product code GGC: Control, Plasma, Abnormal
GGC is the FDA product code for control, plasma, abnormal. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel. FDA has cleared 40 510(k) submissions under GGC, from 24 different applicants. The average 510(k) review took 121 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Control, Plasma, Abnormal |
| Device class | Class II |
| Regulation | 21 CFR 864.5425 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GGC clearance
Top GGC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Bioproducts Co. | 5 | 1996-01-31 |
| Medical Diagnostic Technologies, Inc. | 4 | 1996-05-24 |
| Analytical Control Systems, Inc. | 4 | 1989-08-03 |
| Behring Diagnostics, Inc. | 3 | 1994-02-22 |
| Helena Laboratories | 2 | 2010-12-15 |
19 more applicants have GGC clearances. See the full list in Caduvo.
Most recent GGC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K102552 | Instrumentation Laboratory CO | HEMOSIL LA POSITIVE CONTROL | 2011-04-05 | 210 |
| K100103 | Helena Laboratories | SPECIALTY ASSAYED CONTROL-2 | 2010-12-15 | 336 |
| K062306 | R2 Diagnostics, Inc. | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | 2007-03-16 | 220 |
| K061803 | Diagnostica Stago, Inc. | STA - CONTROL LA 1+2 | 2006-07-28 | 31 |
| K032804 | Precision Biologic | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | 2003-11-03 | 55 |
Recalls for GGC devices
openFDA lists no recalls for product code GGC.
Frequently asked questions
What is FDA product code GGC?
GGC is the FDA product code for control, plasma, abnormal. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel.
What device class is GGC?
Class II, regulation 21 CFR 864.5425. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGC?
Across 40 cleared submissions the average was 121 days from receipt to decision (median 54).
Which companies have the most GGC clearances?
American Bioproducts Co. (5); Medical Diagnostic Technologies, Inc. (4); Analytical Control Systems, Inc. (4); Behring Diagnostics, Inc. (3); Helena Laboratories (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GGC
- Run a recall and safety report across every GGC manufacturer
- Watch product code GGC 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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