Aia-Pack T-U
FDA 510(k) K913663 · Tosoh Corp.
510(k) numberK913663
Submission
- Device name
- Aia-Pack T-U
- Applicant
- Tosoh Corp.
Washington, D.C., DC, US - Received
- August 16, 1991
- Decision date
- September 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KHQ – Radioassay, Triiodothyronine Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1715
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KHQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K981375 | Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional | Schiapparelli Biosystems, Inc. | 06/10/1998SE |
| K980088 | T-Uptake Microplate EiaKHQ · Traditional | Monobind | 02/04/1998SE |
| K970539 | Chiron Diagnostics ACS:180TU PKHQ · Traditional | Chiron Diagnostics Corp. | 03/24/1997SE |
| K964308 | Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (GEM.1025) and T3 Uptake…KHQ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 11/27/1996SE |
| K961488 | Elecsys T-Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 06/12/1996SE |
| K954807 | Cedia T Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 12/21/1995SE |
| K951586 | T-Uptake Eia TestKHQ · Traditional | Diagnostic Reagents, Inc. | 05/15/1995SE |
| K933414 | Stratus(R) Thyroid Uptake Fluor Enzyme ImmunoassayKHQ · Traditional | Baxter Diagnostics, Inc. | 11/22/1994SE |
| K934312 | Axsym(Tm) T-UptakeKHQ · Traditional | Abbott Laboratories | 06/21/1994SE |
| K935816 | Vidas T UptakeKHQ · Traditional | Biomerieux Vitek, Inc. | 03/22/1994SE |
More from Biomerieux Vitek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023240 | ST Aia-Pack Ca 19-9NIG · Traditional | 12/23/2002SE |
| K023239 | Aia-Pack Ca 19-9NIG · Traditional | 12/23/2002SE |
| K923021 | AIA-1200DX - Automated Enzyme Immunoassay SystemKHO · Traditional | 07/21/1992SE |
| K913298 | Aia-Pack Ck-MbJHX · Traditional | 09/27/1991SE |
| K913493 | Aia-Pack FT4CEC · Traditional | 09/10/1991SE |
| K903628 | Aia-Pack IriCFP · Traditional | 09/07/1990SE |
| K901965 | MPR-4A - Micro-Plate ReaderJJQ · Traditional | 05/10/1990SE |
| K901674 | AIA-600 Automated Enzyme Immunoassay SystemKHO · Traditional | 05/02/1990SE |
| K897001 | Tosoh Aia-Pack T3CDP · Traditional | 03/09/1990SE |
| K896982 | Aia-Pack T4KLI · Traditional | 03/09/1990SE |
Questions and answers
When was Aia-Pack T-U cleared by the FDA?
Aia-Pack T-U (K913663) received a 510(k) decision of Substantially Equivalent on September 30, 1991, 45 days after the submission was received.
What is the product code of K913663?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.