The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Acth.
| Device ID | K960066 |
| 510k Number | K960066 |
| Device Name: | IMMULITE ACTH |
| Classification | Radioimmunoassay, Acth |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine, Phd. |
| Correspondent | Edward M Levine, Phd. DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-05 |
| Decision Date | 1996-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963532 | K960066 | 000 |
| 00630414960999 | K960066 | 000 |
| 00630414953502 | K960066 | 000 |