The following data is part of a premarket notification filed by Toyo Jozo Co., Ltd. with the FDA for Lipase Color [toyo] Serum Lipase Test Kit.
| Device ID | K897150 |
| 510k Number | K897150 |
| Device Name: | LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | TOYO JOZO CO., LTD. INTL. SQUARE 1825 EYE ST., N.W. SUITE 400 Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney TOYO JOZO CO., LTD. INTL. SQUARE 1825 EYE ST., N.W. SUITE 400 Washington, DC 20006 |
| Product Code | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-26 |
| Decision Date | 1990-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400782 | K897150 | 000 |
| 00811727013613 | K897150 | 000 |
| 00811727011817 | K897150 | 000 |
| 00811727011800 | K897150 | 000 |
| 00811727011794 | K897150 | 000 |
| 00817439021038 | K897150 | 000 |