JGP
5 FDA 510(k) clearances · Product code
69 daysmedian time to decision
259 days90th percentile
5clearances measured
FDA profile
- Official device name
- Lowry (Colorimetric), Total Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1635
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MICROPROTEIN REAGENT SET (K070757) | Pointe Scientific, Inc., | 2007-12-04 |
| VITROS CHEMISTRY PRODUCTS UPRO SLIDES (K964960) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-18 |
| PROTEINMETER (K863112) | J. D. Assoc. | 1986-12-10 |
| HEMATOLOGY DATA MANAGEMENT SYS (K821534) | Biovation, Inc. | 1982-06-10 |
| MICRO LOWRY PROTEINTEST (K792347) | Panmed, Inc. | 1979-12-06 |
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Every clearance here is in the API, with alerts when new ones post.