The following data is part of a premarket notification filed by Chemtrak, Inc. with the FDA for Accumeter Theophylline Test.
| Device ID | K972495 |
| 510k Number | K972495 |
| Device Name: | ACCUMETER THEOPHYLLINE TEST |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | CHEMTRAK, INC. 929 EAST ARQUES AVE. Sunnyvale, CA 94086 -4520 |
| Contact | Subbarao Gunupudi |
| Correspondent | Subbarao Gunupudi CHEMTRAK, INC. 929 EAST ARQUES AVE. Sunnyvale, CA 94086 -4520 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1997-10-10 |
| Summary: | summary |