Fiax Test Kit for Ena (Rnp/Sm) Antibodies
FDA 510(k) K873708 · Whittaker Bioproducts, Inc.
510(k) numberK873708
Submission
- Device name
- Fiax Test Kit for Ena (Rnp/Sm) Antibodies
- Applicant
- Whittaker Bioproducts, Inc.
Walkersville, MD, US - Received
- September 15, 1987
- Decision date
- November 25, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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More from Immco Diagnostics, Inc.
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|---|---|---|
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| K904652 | Lyme Stat M Test KitLSR · Traditional | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | 10/16/1991SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | 09/25/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | 05/07/1991SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | 06/27/1990SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | 01/16/1990SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | 10/16/1989SE |
Questions and answers
When was Fiax Test Kit for Ena (Rnp/Sm) Antibodies cleared by the FDA?
Fiax Test Kit for Ena (Rnp/Sm) Antibodies (K873708) received a 510(k) decision of Substantially Equivalent on November 25, 1987, 71 days after the submission was received.
What is the product code of K873708?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.