The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Thyroid Autoantibody Control Module.
| Device ID | K971051 |
| 510k Number | K971051 |
| Device Name: | IMMULITE THYROID AUTOANTIBODY CONTROL MODULE |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414953335 | K971051 | 000 |