Stratus(R) Thyroid Uptake Fluor Enzyme Immunoassay
FDA 510(k) K933414 · Baxter Diagnostics, Inc.
510(k) numberK933414
Submission
- Device name
- Stratus(R) Thyroid Uptake Fluor Enzyme Immunoassay
- Applicant
- Baxter Diagnostics, Inc.
Miami, FL, US - Received
- July 13, 1993
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| K954807 | Cedia T Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 12/21/1995SE |
| K951586 | T-Uptake Eia TestKHQ · Traditional | Diagnostic Reagents, Inc. | 05/15/1995SE |
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Questions and answers
When was Stratus(R) Thyroid Uptake Fluor Enzyme Immunoassay cleared by the FDA?
Stratus(R) Thyroid Uptake Fluor Enzyme Immunoassay (K933414) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 497 days after the submission was received.
What is the product code of K933414?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.