FDA product code GHM: Test, Sickle Cell
GHM is the FDA product code for test, sickle cell. It is a Class II device, regulated under 21 CFR 864.7825 and reviewed by the Hematology panel. FDA has cleared 18 510(k) submissions under GHM, from 11 different applicants. The average 510(k) review took 51 days (median 38). FDA has posted 5 recalls for GHM devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Sickle Cell |
| Device class | Class II |
| Regulation | 21 CFR 864.7825 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GHM clearance
Top GHM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Isolab, Inc. | 4 | 1991-10-09 |
| Streck Laboratories, Inc. | 2 | 2002-12-30 |
| Pacific Hemostasis | 2 | 1987-07-31 |
| Michclone Associates, Inc. | 2 | 1986-04-11 |
| Anco Medical Reagents & Assoc. | 2 | 1983-07-28 |
6 more applicants have GHM clearances. See the full list in Caduvo.
Most recent GHM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023656 | Streck Laboratories, Inc. | SICKLE-CHEX SOLUBILITY KIT | 2002-12-30 | 61 |
| K013316 | Streck Laboratories, Inc. | SICKLE-CHEX | 2001-11-06 | 33 |
| K960947 | Sa Scientific, Inc. | SAS SICKLE CELL TEST | 1996-07-01 | 115 |
| K911981 | Isolab, Inc. | HEMOCARD HEMOGLOBIN S | 1991-10-09 | 159 |
| K910430 | Isolab, Inc. | HEMOCARD-AS | 1991-04-15 | 73 |
Recalls for GHM devices
5 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-02-23.
Frequently asked questions
What is FDA product code GHM?
GHM is the FDA product code for test, sickle cell. It is a Class II device, regulated under 21 CFR 864.7825 and reviewed by the Hematology panel.
What device class is GHM?
Class II, regulation 21 CFR 864.7825. Typical premarket route: 510(k).
How long does a 510(k) take for product code GHM?
Across 18 cleared submissions the average was 51 days from receipt to decision (median 38).
Which companies have the most GHM clearances?
Isolab, Inc. (4); Streck Laboratories, Inc. (2); Pacific Hemostasis (2); Michclone Associates, Inc. (2); Anco Medical Reagents & Assoc. (2).
Have GHM devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2012-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code GHM
- Run a recall and safety report across every GHM manufacturer
- Watch product code GHM 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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