The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Anti-tpo-ab(lktoi,lkt05,lktoz.
Device ID | K963695 |
510k Number | K963695 |
Device Name: | IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ |
Classification | System, Test, Thyroid Autoantibody |
Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
Contact | Edward M Levine, Ph.d. |
Correspondent | Edward M Levine, Ph.d. DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
Product Code | JZO |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-16 |
Decision Date | 1997-01-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414964744 | K963695 | 000 |