DIRECT GLUCOSE REAGENT SET
FDA 510(k) clearance K841054 · decided 1984-05-01
Clearance details
- K-number
- K841054
- Device name
- DIRECT GLUCOSE REAGENT SET
- Applicant
- Medical Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-12
- Decision date
- 1984-05-01
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- CGE
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (K890335) | Alpkem Corp. | 1989-02-17 |
| GLUCOSE REAGENT SET (K855185) | Technostics Intl. | 1986-01-22 |
| GLUCOSE (K850930) | Dilab, Inc. | 1985-06-10 |
| DIRECT GLUCOSE REAGENT SET (K821198) | Omega Medical Electronics | 1982-07-13 |
| KING DIAGNOSTICS GLUCOSE-O TEST (K811883) | King Diagnostics, Inc. | 1981-07-23 |
| 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI (K810089) | Anco Medical Reagents & Assoc. | 1981-01-26 |
| ORTHO-TOLUIDINE REAGENT SET (K790319) | Fisher Scientific Co., LLC | 1979-03-21 |
| GLUCOLOUR (K781308) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| GLUCOSE REAGENT (O-TOLUIDINE) (K771314) | Mallinckrodt Critical Care | 1977-08-03 |
| UNIPAK GLUCOSE (K771091) | Harleco | 1977-07-21 |
| GLUCOSE PROCEDURE, TEKPOINT DIRECT (K770455) | Icn Pharmaceuticals, Inc. | 1977-05-03 |
Recalls involving this device
No recalls on record reference this clearance.