The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Chemelia Enzyme Immunoassay For (tsh).
| Device ID | K873625 |
| 510k Number | K873625 |
| Device Name: | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) |
| Classification | Isoenzymes, Electrophoretic, Glucose-6-phosphate Dehydrogenase |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Contact | John Simpson |
| Correspondent | John Simpson BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Product Code | JLM |
| CFR Regulation Number | 864.7360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-08 |
| Decision Date | 1987-10-20 |