The following data is part of a premarket notification filed by Tosoh Corp. with the FDA for Mpr-4a - Micro-plate Reader.
| Device ID | K901965 |
| 510k Number | K901965 |
| Device Name: | MPR-4A - MICRO-PLATE READER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Howard Holstein |
| Correspondent | Howard Holstein TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-05-10 |