FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO LOWRY PROTEINTEST
K Number: K792347
·
Decision Dec 6, 1979
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
4
Applicant Total
16
Review Days
17
Basic Information
- Device Name
- MICRO LOWRY PROTEINTEST
- K Number
- K792347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- PANMED, INC.
- Date Received
- November 19, 1979
- Decision Date
- December 6, 1979
- Product Code
- JGP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JGP | Lowry (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGP), ordered by most recent decision date.
MICROPROTEIN REAGENT SET
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VITROS CHEMISTRY PRODUCTS UPRO SLIDES
FDA 510(k)
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PROTEINMETER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEMATOLOGY DATA MANAGEMENT SYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by PANMED, INC.
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|---|---|---|---|
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| K802157 | BCG REAGENT SERUM ALBUMIN W/TECHNICON | Oct 10, 1980 | Substantially Equivalent |
| K802154 | REAGENTS USED-QUAN. MEASURE OF SERUM | Oct 10, 1980 | Substantially Equivalent |
| K802163 | CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent |
| K802161 | BIURET REAGENT & TOTAL PROTEIN BLANK SOL | Oct 10, 1980 | Substantially Equivalent |
| K802159 | AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS | Oct 10, 1980 | Substantially Equivalent |
| K802164 | 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. | Oct 10, 1980 | Substantially Equivalent |
| K802158 | POSTASSIUM BUFFER SOL. & WASH SOLUTION | Oct 10, 1980 | Substantially Equivalent |