Rheumelisa II JO-1 Antibody Test Kit
FDA 510(k) K930757 · Biowhittaker Molecular Applications, Inc.
510(k) numberK930757
Submission
- Device name
- Rheumelisa II JO-1 Antibody Test Kit
- Applicant
- Biowhittaker Molecular Applications, Inc.
Walkersville, MD, US - Received
- February 12, 1993
- Decision date
- March 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | Inova Diagnostics, Inc. | 06/25/2018SE |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL · Traditional | Inova Diagnostics, Inc. | 06/01/2016SE |
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| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | Immco Diagnostics, Inc. | 03/31/2015SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943843 | Varicelisa, ModificationLFY · Traditional | 03/14/1996SE |
| K942361 | WhitsoftJJQ · Traditional | 04/04/1995SE |
| K942250 | Biowhittaker Cartridge Software for EIA-400 Plate ReaderJJQ · Traditional | 04/04/1995SE |
| K942245 | Biowhittaker 2001 Microplate Reader FirmwareJJQ · Traditional | 04/03/1995SE |
| K925209 | Mumps StatLJY · Traditional | 10/14/1994SE |
| K935618 | Specimen Transport MediumJSM · Traditional | 04/21/1994SE |
| K932679 | Rheumelisa II Histone Antibody Test KitLKJ · Traditional | 08/23/1993SE |
| K930130 | Rheumelisa II SCL-70 Antibody Test KitLLL · Traditional | 03/23/1993SE |
| K920753 | RF Stat Igm Test KitDHR · Traditional | 03/30/1992SE |
Questions and answers
When was Rheumelisa II JO-1 Antibody Test Kit cleared by the FDA?
Rheumelisa II JO-1 Antibody Test Kit (K930757) received a 510(k) decision of Substantially Equivalent on March 26, 1993, 42 days after the submission was received.
What is the product code of K930757?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.