Access Thyroid Uptake Assay
FDA 510(k) K930010 · Bio-Rad Laboratories, Inc.
510(k) numberK930010
Submission
- Device name
- Access Thyroid Uptake Assay
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- January 4, 1993
- Decision date
- June 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEE – Radioimmunoassay, Thyroxine-Binding Globulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1685
- Specialty
- Clinical Chemistry
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| K862109 | Enzymun Test TBGCEE · Traditional | Boehringer Mannheim Corp. | 06/30/1986SE |
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Questions and answers
When was Access Thyroid Uptake Assay cleared by the FDA?
Access Thyroid Uptake Assay (K930010) received a 510(k) decision of Substantially Equivalent on June 7, 1993, 154 days after the submission was received.
What is the product code of K930010?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.