The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Turbo Troponin I, Models Lskti1, Lskti5.
Device ID | K991795 |
510k Number | K991795 |
Device Name: | IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 |
Classification | Immunoassay Method, Troponin Subunit |
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 | MMI |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-26 |
Decision Date | 1999-06-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414986081 | K991795 | 000 |