Acs FRT4 Immunoassay
FDA 510(k) K961510 · Ciba Corning Diagnostics Corp.
510(k) numberK961510
Submission
- Device name
- Acs FRT4 Immunoassay
- Applicant
- Ciba Corning Diagnostics Corp.
Irvine, CA, US - Received
- April 19, 1996
- Decision date
- June 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Siemens Healthcare Diagnostics, Inc.
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|---|---|---|
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | 11/05/1996SE |
| K963251 | Ciba Corning ACS;180 DPD AssayJMM · Traditional | 10/15/1996SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
| K954697 | Ciba Corning Acs ESTRADIOL-6 AssayCHP · Traditional | 12/13/1995SE |
Questions and answers
When was Acs FRT4 Immunoassay cleared by the FDA?
Acs FRT4 Immunoassay (K961510) received a 510(k) decision of Substantially Equivalent on June 17, 1996, 59 days after the submission was received.
What is the product code of K961510?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.