The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Hcg, Model Lkcg1, Lccg5, Immulite 2000 Hcg, Model L2kcg2, L2kcg6.
Device ID | K990222 |
510k Number | K990222 |
Device Name: | IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 |
Classification | System, Test, Human Chorionic Gonadotropin |
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 | DHA |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-25 |
Decision Date | 1999-02-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414973173 | K990222 | 000 |
00630414973067 | K990222 | 000 |
00630414965758 | K990222 | 000 |
00630414961149 | K990222 | 000 |
00630414961132 | K990222 | 000 |
00630414953861 | K990222 | 000 |