FDA product code KHQ: Radioassay, Triiodothyronine Uptake
KHQ is the FDA product code for radioassay, triiodothyronine uptake. It is a Class II device, regulated under 21 CFR 862.1715 and reviewed by the Clinical Chemistry panel. FDA has cleared 93 510(k) submissions under KHQ, from 68 different applicants. The average 510(k) review took 60 days (median 41). FDA has posted 1 recall for KHQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioassay, Triiodothyronine Uptake |
| Device class | Class II |
| Regulation | 21 CFR 862.1715 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KHQ clearance
Top KHQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 5 | 1992-10-09 |
| Abbott Laboratories | 3 | 1994-06-21 |
| Ciba Corning Diagnostics Corp. | 3 | 1992-12-28 |
| Amersham Corp. | 3 | 1988-02-18 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1987-07-09 |
63 more applicants have KHQ clearances. See the full list in Caduvo.
Most recent KHQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981375 | Schiapparelli Biosystems, Inc. | ACE T UPTAKE REAGENT TU CALIBRATORS | 1998-06-10 | 55 |
| K980088 | Monobind | T-UPTAKE MICROPLATE EIA | 1998-02-04 | 26 |
| K970539 | Chiron Diagnostics Corp. | CHIRON DIAGNOSTICS ACS:180TU P | 1997-03-24 | 40 |
| K964308 | Johnson & Johnson Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) | 1996-11-27 | 29 |
| K961488 | Boehringer Mannheim Corp. | ELECSYS T-UPTAKE ASSAY | 1996-06-12 | 55 |
Recalls for KHQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code KHQ?
KHQ is the FDA product code for radioassay, triiodothyronine uptake. It is a Class II device, regulated under 21 CFR 862.1715 and reviewed by the Clinical Chemistry panel.
What device class is KHQ?
Class II, regulation 21 CFR 862.1715. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHQ?
Across 93 cleared submissions the average was 60 days from receipt to decision (median 41).
Which companies have the most KHQ clearances?
Syva Co. (5); Abbott Laboratories (3); Ciba Corning Diagnostics Corp. (3); Amersham Corp. (3); Bd Becton Dickinson Vacutainer Systems Preanalytic (3).
Have KHQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code KHQ
- Run a recall and safety report across every KHQ manufacturer
- Watch product code KHQ 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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