510(k) K863112
- Device
- PROTEINMETER
- Applicant
- J. D. ASSOC.
- 510(k) number
- K863112
- Product code
- JGP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-12-10
- Date received
- 1986-08-13
- Regulation
- 862.1635
- Classification name
- Lowry (colorimetric), Total Protein
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DI PIETRO
- Address
- 163 Montclair Ave. Montclair NJ US 07042 07042
FDA Registration Numbers#
- 1319809
- 3012963943
- 2250051
- 3014325803
- 1319808
- 1319681
- 8040374
- 3002642396
- 3000308930
- 1827821
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 |
| K821534 | HEMATOLOGY DATA MANAGEMENT SYS | Biovation, Inc. | 1982-06-10 |
| K792347 | MICRO LOWRY PROTEINTEST | Panmed, Inc. | 1979-12-06 |
Legacy Summary#
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FDA Review#
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