The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline Phosphatase Calibrator.
Device ID | K121907 |
510k Number | K121907 |
Device Name: | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR |
Classification | Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101, MAILSTAP 514 Newark, DE 19714 |
Contact | Rose T Marinelli |
Correspondent | Rose T Marinelli SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101, MAILSTAP 514 Newark, DE 19714 |
Product Code | CJO |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-29 |
Decision Date | 2012-07-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414601199 | K121907 | 000 |
00630414600611 | K121907 | 000 |
00842768039027 | K121907 | 000 |
00842768039010 | K121907 | 000 |