The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Calibrator B Level 1(cutoff) & Level 2(high).
| Device ID | K912729 |
| 510k Number | K912729 |
| Device Name: | EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) |
| Classification | Calibrators, Drug Mixture |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-20 |
| Decision Date | 1991-07-22 |