The following data is part of a premarket notification filed by Eqm Research, Inc. with the FDA for Test-mate Che Cholinesterase Test System.
| Device ID | K961656 |
| 510k Number | K961656 |
| Device Name: | TEST-MATE CHE CHOLINESTERASE TEST SYSTEM |
| Classification | Colorimetry, Cholinesterase |
| Applicant | EQM RESEARCH, INC. 2585 MONTANA AVE. Cincinnati, OH 45211 |
| Contact | J. Patrick Eberly |
| Correspondent | J. Patrick Eberly EQM RESEARCH, INC. 2585 MONTANA AVE. Cincinnati, OH 45211 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-30 |
| Decision Date | 1996-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010612224 | K961656 | 000 |
| 00860010612217 | K961656 | 000 |
| 00860010612200 | K961656 | 000 |