510(k) K821534
- Device
- HEMATOLOGY DATA MANAGEMENT SYS
- Applicant
- BIOVATION, INC.
- 510(k) number
- K821534
- Product code
- JGP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-10
- Date received
- 1982-05-24
- Regulation
- 862.1635
- Classification name
- Lowry (colorimetric), Total Protein
- Medical specialty
- Clinical Chemistry
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 8040374
- 3014325803
- 3012963943
- 3002642396
- 1827821
- 2250051
- 1319809
- 1319808
- 3000308930
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JGP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | Pointe Scientific, Inc., | 2007-12-04 |
| K964960 | VITROS CHEMISTRY PRODUCTS UPRO SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-18 |
| K863112 | PROTEINMETER | J. D. Assoc. | 1986-12-10 |
| K792347 | MICRO LOWRY PROTEINTEST | Panmed, Inc. | 1979-12-06 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases