The following data is part of a premarket notification filed by Kyowa Medex Co., Ltd. with the FDA for Point Checker Color Strip Thermometer.
| Device ID | K894893 |
| 510k Number | K894893 |
| Device Name: | POINT CHECKER COLOR STRIP THERMOMETER |
| Classification | Thermometer, Clinical Color Change |
| Applicant | KYOWA MEDEX CO., LTD. 1401 WILSON BLVD. SUITE 400 Arlington, VA 22209 |
| Contact | Lynne N Seekamp |
| Correspondent | Lynne N Seekamp KYOWA MEDEX CO., LTD. 1401 WILSON BLVD. SUITE 400 Arlington, VA 22209 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1990-04-05 |