The following data is part of a premarket notification filed by Rapid Diagnostic Laboratories, Inc. with the FDA for High Performance Calibrators.
| Device ID | K875216 |
| 510k Number | K875216 |
| Device Name: | HIGH PERFORMANCE CALIBRATORS |
| Classification | Calibrators, Drug Mixture |
| Applicant | RAPID DIAGNOSTIC LABORATORIES, INC. C/O EASTERN LABORATORIES LTD. 95 SEAVIEW BOULEVARD Port Washington, NY 11050 |
| Contact | Amiya Dhar |
| Correspondent | Amiya Dhar RAPID DIAGNOSTIC LABORATORIES, INC. C/O EASTERN LABORATORIES LTD. 95 SEAVIEW BOULEVARD Port Washington, NY 11050 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-06-22 |