The following data is part of a premarket notification filed by Salimetrics Llc. with the FDA for Progesterone Standard Calibrator, One (1) Ml Of Progesterone In A Saliva-like Matrix At A Concentration Of 2430 Pg/ml..
| Device ID | K051012 |
| 510k Number | K051012 |
| Device Name: | PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. |
| Classification | Calibrator, Secondary |
| Applicant | SALIMETRICS LLC. 101 INNOVATION BLVD. SUITE 302 State College, PA 16803 -6605 |
| Contact | Virginia Mckay Mckay |
| Correspondent | Virginia Mckay Mckay SALIMETRICS LLC. 101 INNOVATION BLVD. SUITE 302 State College, PA 16803 -6605 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-21 |
| Decision Date | 2005-07-19 |