The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Emit Calibrator B Level 1 (cutoff)/emit Calibrator B Level 2 (high).
| Device ID | K971600 |
| 510k Number | K971600 |
| Device Name: | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) |
| Classification | Calibrators, Drug Mixture |
| Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | David Kolejail |
| Correspondent | David Kolejail BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768001802 | K971600 | 000 |
| 00842768001796 | K971600 | 000 |