The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Acth Control Module (laccm).
Device ID | K963240 |
510k Number | K963240 |
Device Name: | IMMULITE ACTH CONTROL MODULE (LACCM) |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
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 | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-19 |
Decision Date | 1996-08-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414953090 | K963240 | 000 |