FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MICRO LOWRY PROTEINTEST

K Number: K792347 · Decision Dec 6, 1979
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
4
Applicant Total
16
Review Days
17

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

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
JGP Lowry (Colorimetric), Total Protein

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (JGP), ordered by most recent decision date.

View all

Other Clearances by Panmed, Inc.

K Number Device Name
K852767 ERYTHOCYTE CREATINE
K820642 SICKLE-CHECK
K802155 REAGENTS SERUM SODIUM USING THE TECH.
K802158 POSTASSIUM BUFFER SOL. & WASH SOLUTION
K802162 CO2 COLOR REAGENT & CO2 SAMPLE DILUENT
K802156 REAGENTS SERUM CREATINE USING TECHICON
K802163 CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT
K802157 BCG REAGENT SERUM ALBUMIN W/TECHNICON
K802159 AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS
K802160 BUN COLOR REAGENT & BUN ACID USED
Search all 16 clearances from Panmed, Inc. →