The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Glucose-sl Assay, Catalogue No. 235-60.
| Device ID | K961282 |
| 510k Number | K961282 |
| Device Name: | GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 |
| Classification | Hexokinase, Glucose |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-03 |
| Decision Date | 1996-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400539 | K961282 | 000 |
| 00628063400522 | K961282 | 000 |
| 00628063400515 | K961282 | 000 |
| 00811727011183 | K961282 | 000 |
| 00811727011176 | K961282 | 000 |
| 00811727011169 | K961282 | 000 |
| 00811727016157 | K961282 | 000 |
| 00811727015846 | K961282 | 000 |