Cleared Traditional

K791711 - IMPROVED GRAM STAIN REAGENTS (FDA 510(k) Clearance)

K791711 · Carr-Scarborough Microbiologicals, Inc. · Microbiology device

Oct 1979

Decision

50d

Days

Class 1

Risk

K791711 is an FDA 510(k) clearance for the IMPROVED GRAM STAIN REAGENTS. This device is classified as a Iodine, Grams (Class I - General Controls, product code HYI).

Submitted by Carr-Scarborough Microbiologicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979, 50 days after receiving the submission on August 28, 1979.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K791711 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 28, 1979
Decision Date	October 17, 1979
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—