Micro Lowry Proteintest
FDA 510(k) K792347 · Panmed, Inc.
510(k) numberK792347
Submission
- Device name
- Micro Lowry Proteintest
- Applicant
- Panmed, Inc.
Mchenry, IL, US - Received
- November 19, 1979
- Decision date
- December 6, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGP – Lowry (Colorimetric), Total Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1635
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070757 | Microprotein Reagent SetJGP · Traditional | Pointe Scientific, Inc., | 12/04/2007SE |
| K964960 | Vitros Chemistry Products Upro SlidesJGP · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/18/1997SE |
| K863112 | ProteinmeterJGP · Traditional | J. D. Assoc. | 12/10/1986SE |
| K821534 | Hematology Data Management SysJGP · Traditional | Biovation, Inc. | 06/10/1982SE |
More from Biovation, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K852767 | Erythocyte CreatineJLA · Traditional | 11/13/1986SE |
| K820642 | Sickle-CheckGHM · Traditional | 04/14/1982SE |
| K802164 | 8-HYDROXYQUINOLINE, Cresolphthalein Com.CIC · Traditional | 10/10/1980SE |
| K802163 | Chloride Color & Chloride Sample DiluentCHJ · Traditional | 10/10/1980SE |
| K802162 | CO2 Color Reagent & CO2 Sample DiluentKMS · Traditional | 10/10/1980SE |
| K802161 | Biuret Reagent & Total Protein Blank SolCEK · Traditional | 10/10/1980SE |
| K802160 | Bun Color Reagent & Bun Acid UsedCDW · Traditional | 10/10/1980SE |
| K802159 | Ammonium Molybdate Inorganic PhosphorusCEO · Traditional | 10/10/1980SE |
| K802158 | Postassium Buffer Sol. & Wash SolutionCEM · Traditional | 10/10/1980SE |
| K802157 | BCG Reagent Serum Albumin W/TechniconCIX · Traditional | 10/10/1980SE |
Questions and answers
When was Micro Lowry Proteintest cleared by the FDA?
Micro Lowry Proteintest (K792347) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 17 days after the submission was received.
What is the product code of K792347?
The FDA product code is JGP – Lowry (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.