The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Vitamin B12, Model L2kvb2, L2kvb6.
| Device ID | K993251 |
| 510k Number | K993251 |
| Device Name: | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 |
| Classification | Radioassay, Intrinsic Factor Blocking Antibody |
| 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 | LIG |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-28 |
| Decision Date | 1999-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414962320 | K993251 | 000 |
| 00630414962313 | K993251 | 000 |