510(k) K771091
- Device
- UNIPAK GLUCOSE
- Applicant
- Harleco
- 510(k) number
- K771091
- Product code
- CGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-21
- Date received
- 1977-06-16
- Regulation
- 862.1345
- Classification name
- Orthotoluidine, Glucose
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CGE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Alpkem Corp. | 1989-02-17 |
| K855185 | GLUCOSE REAGENT SET | Technostics Intl. | 1986-01-22 |
| K850930 | GLUCOSE | Dilab, Inc. | 1985-06-10 |
| K841054 | DIRECT GLUCOSE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 |
| K821198 | DIRECT GLUCOSE REAGENT SET | Omega Medical Electronics | 1982-07-13 |
| K811883 | KING DIAGNOSTICS GLUCOSE-O TEST | King Diagnostics, Inc. | 1981-07-23 |
| K810089 | 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI | Anco Medical Reagents & Assoc. | 1981-01-26 |
| K790319 | ORTHO-TOLUIDINE REAGENT SET | Fisher Scientific Co., LLC | 1979-03-21 |
| K781308 | GLUCOLOUR | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| K771314 | GLUCOSE REAGENT (O-TOLUIDINE) | Mallinckrodt Critical Care | 1977-08-03 |
| K770455 | GLUCOSE PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-05-03 |