The following data is part of a premarket notification filed by Biotest Medical Corp. with the FDA for Easy Plus Ii Blood Glucose Monitoring System,easy Plus Ii Multi Blood Glucose Monitoring System,smartest Persona Ii Bloo.
| Device ID | K133509 |
| 510k Number | K133509 |
| Device Name: | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Biotest Medical Corp. 1 INDUSTRIAL WAY WEST/ BUILDING E, SUITE G&H Eatontown, NJ 07724 |
| Contact | Robert Nawy |
| Correspondent | Robert Nawy Biotest Medical Corp. 1 INDUSTRIAL WAY WEST/ BUILDING E, SUITE G&H Eatontown, NJ 07724 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-14 |
| Decision Date | 2014-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712803564141 | K133509 | 000 |