The following data is part of a premarket notification filed by Gds Technology, Llc. with the FDA for Gds Enzymatic Acetaminophen Reagent.
| Device ID | K880829 |
| 510k Number | K880829 |
| Device Name: | GDS ENZYMATIC ACETAMINOPHEN REAGENT |
| Classification | Colorimetry, Acetaminophen |
| Applicant | GDS TECHNOLOGY, LLC. 25235 LEER DR. P.O. BOX 473 Elkhart, IN 46515 |
| Contact | De Castro |
| Correspondent | De Castro GDS TECHNOLOGY, LLC. 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 | 1988-03-01 |
| Decision Date | 1988-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208139 | K880829 | 000 |