ACETASITE
Colorimetry, Acetaminophen
GDS DIAGNOSTICS
The following data is part of a premarket notification filed by Gds Diagnostics with the FDA for Acetasite.
Pre-market Notification Details
| Device ID | K931257 |
| 510k Number | K931257 |
| Device Name: | ACETASITE |
| Classification | Colorimetry, Acetaminophen |
| Applicant | GDS DIAGNOSTICS 25235 LEER DR. P.O. BOX 473 Elkhart, IN 46515 |
| Contact | De Castro |
| Correspondent | De Castro GDS DIAGNOSTICS 25235 LEER DR. P.O. BOX 473 Elkhart, IN 46515 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-12 |
| Decision Date | 1993-07-08 |
Trademark Results [ACETASITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACETASITE 74708168 1981204 Dead/Cancelled |
GDS TECHNOLOGY, INC. 1995-07-31 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.