FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

BLENDED DETERGENT-78N 1912-1

K Number: K822326 · Decision Oct 18, 1982
Classifications
1
FEI Numbers
258
Registration Numbers
258
Same Product Code
15
Applicant Total
4
Review Days
76

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
BLENDED DETERGENT-78N 1912-1
K Number
K822326
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
864.4010
Medical Specialty
Pathology
Decision
Substantially Equivalent
Applicant
Interscience, Inc.
Date Received
August 3, 1982
Decision Date
October 18, 1982
Product Code
PPM
Advisory Committee
Pathology
Review Advisory Committee
HE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
PPM General Purpose Reagent

Similar 510(k) Clearances

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

View all

Other Clearances by Interscience, Inc.

K Number Device Name
K822327 CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT
K822324 RED CELL LYSING REAGENT 78N 1915-1
K822325 BLOOD CELL DILUENT 78N 1913