The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Drug Standard Set.
| Device ID | K884177 |
| 510k Number | K884177 |
| Device Name: | DRUG STANDARD SET |
| Classification | Calibrators, Drug Mixture |
| Applicant | GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Contact | Angelo Pereira |
| Correspondent | Angelo Pereira GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-04 |
| Decision Date | 1989-02-17 |