The following data is part of a premarket notification filed by Franklin Diagnostics, Inc. with the FDA for Franklin Collector(r).
| Device ID | K884612 |
| 510k Number | K884612 |
| Device Name: | FRANKLIN COLLECTOR(R) |
| Classification | Thermometer, Clinical Color Change |
| Applicant | FRANKLIN DIAGNOSTICS, INC. 60 FRANKLIN ST. Morristown, NJ 07960 |
| Contact | L Ehrenkranz |
| Correspondent | L Ehrenkranz FRANKLIN DIAGNOSTICS, INC. 60 FRANKLIN ST. Morristown, NJ 07960 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-04 |
| Decision Date | 1989-03-27 |