FDA product code KHG: Whole Blood Hemoglobin Determination
KHG is the FDA product code for whole blood hemoglobin determination. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. FDA has cleared 39 510(k) submissions under KHG, 1 in the last five years, from 32 different applicants. The average 510(k) review took 83 days (median 47). FDA has posted 1 recall for KHG devices.
Classification
| Field | Value |
|---|---|
| Device name | Whole Blood Hemoglobin Determination |
| Device class | Class II |
| Regulation | 21 CFR 864.7500 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KHG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 301 |
| 2023 | 1 | 493 |
Compare with all 510(k) review times · Search every KHG clearance
Top KHG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 4 | 1982-07-30 |
| Gds Technology, LLC | 2 | 2000-01-14 |
| Abbott Laboratories | 2 | 1995-09-29 |
| Boehringer Mannheim Corp. | 2 | 1993-12-06 |
| Marilyn L. Amick | 2 | 1980-11-12 |
27 more applicants have KHG clearances. See the full list in Caduvo.
Most recent KHG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221508 | Sanguina, Inc. | AnemoCheck Home | 2023-09-29 | 493 |
| K163215 | Sanguina, LLC | AnemoCheck | 2017-09-13 | 301 |
| K042379 | Biosafe Laboratories, Inc. | ANEMIAPRO SELF-SCREENER | 2004-12-15 | 105 |
| K020138 | Gds Technology | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 | 2002-02-11 | 26 |
| K001462 | Careside, Inc. | CARESIDE HEMOGLOBIN | 2000-08-21 | 103 |
Recalls for KHG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-12-09.
Frequently asked questions
What is FDA product code KHG?
KHG is the FDA product code for whole blood hemoglobin determination. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is KHG?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k).
How long does a 510(k) take for product code KHG?
Across 39 cleared submissions the average was 83 days from receipt to decision (median 47).
Which companies have the most KHG clearances?
Miles Laboratories, Inc. (4); Gds Technology, LLC (2); Abbott Laboratories (2); Boehringer Mannheim Corp. (2); Marilyn L. Amick (2).
Have KHG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-12-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KHG
- Run a recall and safety report across every KHG manufacturer
- Watch product code KHG 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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