The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Crp-advance Multi Calibrator Set, Model Se-250.
Device ID | K060140 |
510k Number | K060140 |
Device Name: | CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 |
Classification | Calibrator, Secondary |
Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, Pe, CA C1e 2a6 |
Contact | Penny White |
Correspondent | Penny White DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, Pe, CA C1e 2a6 |
Product Code | JIT |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-19 |
Decision Date | 2006-04-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00628063401017 | K060140 | 000 |