Cleared Traditional

K780847 - NINHYDRIN REAGENT KIT
(FDA 510(k) Clearance)

K780847 · Beckman Instruments, Inc. · Chemistry device
Jun 1978
Decision
21d
Days
Class 1
Risk

K780847 is an FDA 510(k) clearance for the NINHYDRIN REAGENT KIT. This device is classified as a Ninhydrin, Nitrogen (amino-nitrogen) (Class I - General Controls, product code JMX).

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1978, 21 days after receiving the submission on May 23, 1978.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1515.

Submission Details

510(k) Number K780847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1978
Decision Date June 13, 1978
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JMX — Ninhydrin, Nitrogen (amino-nitrogen)
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.1515