Access Ultrasensitive Insulin Assay
FDA 510(k) K953084 · Bio-Rad Laboratories, Inc.
510(k) numberK953084
Submission
- Device name
- Access Ultrasensitive Insulin Assay
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- July 3, 1995
- Decision date
- September 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFP – Radioimmunoassay, Immunoreactive Insulin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1405
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K963911 | Alpco/Mercodia Insulin ElisaCFP · Traditional | American Laboratory Products Co., Ltd. | 11/01/1996SE |
| K920109 | Imx InsulinCFP · Traditional | Abbott Laboratories | 05/07/1992SE |
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| K903628 | Aia-Pack IriCFP · Traditional | Tosoh Corp. | 09/07/1990SE |
| K901135 | Enzymun Test(R) InsulinCFP · Traditional | Boehringer Mannheim Corp. | 04/03/1990SE |
| K896572 | Rep(Tm) Spe PLUS-30 ProceduresCFP · Traditional | Helena Laboratories | 01/11/1990SE |
| K890837 | Ria-Gnost InsulinCFP · Traditional | Cambridge Medical Technology | 04/26/1989SE |
| K851071 | Pharmacia Insulin RiaCFP · Traditional | Pharmacia, Inc. | 04/12/1985SE |
| K841573 | Insulin Radioimmunoassay KitCFP · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/16/1984SE |
| K823939 | Wako Insulin TestCFP · Traditional | Wako Chemicals USA, Inc. | 01/28/1983SE |
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Questions and answers
When was Access Ultrasensitive Insulin Assay cleared by the FDA?
Access Ultrasensitive Insulin Assay (K953084) received a 510(k) decision of Substantially Equivalent on September 25, 1995, 84 days after the submission was received.
What is the product code of K953084?
The FDA product code is CFP – Radioimmunoassay, Immunoreactive Insulin, a Class I (low risk) device regulated under 21 CFR 862.1405.