The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Carbamazepine, Immulite 2000 Carbamazepine, Catalog # Lkcb1, Lkcb5 & L2kcb2, L2kcb6.
| Device ID | K000007 |
| 510k Number | K000007 |
| Device Name: | IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 |
| Classification | Enzyme Immunoassay, Carbamazepine |
| 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 | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-03 |
| Decision Date | 2000-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963679 | K000007 | 000 |
| 00630414961095 | K000007 | 000 |