Encore Sm/Rnp
FDA 510(k) K921870 · Clark Laboratories, Inc.
510(k) numberK921870
Submission
- Device name
- Encore Sm/Rnp
- Applicant
- Clark Laboratories, Inc.
Blairstown, NJ, US - Received
- April 20, 1992
- Decision date
- December 1, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | Inova Diagnostics, Inc. | 09/29/2023SE |
| K190710 | EliA SymphonyS ImmunoassayLLL · Traditional | Phadia AB | 11/29/2019SE |
| 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 |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsLLL · Traditional | Inova Diagnostics, Inc. | 02/12/2016SE |
| 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 |
|---|---|---|
| K980912 | Vca Igg Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K980596 | Vca Igm Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K980598 | EBNA-1 Igm Elisa Test SystemLLM · Traditional | 05/01/1998SE |
| K973123 | Ea-D Igg Elisa Test SystemLSE · Traditional | 03/26/1998SE |
| K931543 | Encore Ena Combined EiaLLL · Traditional | 09/08/1993SE |
| K925826 | Encore Thyroglobulin Ige, Iga and Igm EiaJZO · Traditional | 01/26/1993SE |
| K923537 | Encore Ds-DnaLRM · Traditional | 12/23/1992SE |
| K921572 | Encore SMLLL · Traditional | 12/01/1992SE |
| K922340 | Encore Ss-BLLL · Traditional | 10/16/1992SE |
| K922157 | Encore Ss-ALLL · Traditional | 10/13/1992SE |
Questions and answers
When was Encore Sm/Rnp cleared by the FDA?
Encore Sm/Rnp (K921870) received a 510(k) decision of Substantially Equivalent on December 1, 1992, 225 days after the submission was received.
What is the product code of K921870?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.