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FDA 510(k)

RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE

K-Number: K860301 · 1986-02-06

ApplicantCarr-Scarborough Microbiologicals, Inc.
Decision Date1986-02-06
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Carr-Scarborough Microbiologicals, Inc.. It received FDA 510(k) clearance on 1986-02-06 under 510(k) number K860301. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE?

RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE is a medical device that received FDA 510(k) clearance on 1986-02-06. The listed applicant is Carr-Scarborough Microbiologicals, Inc.. The 510(k) number is K860301.

When did RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE receive FDA 510(k) clearance?

RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE received FDA 510(k) clearance on 1986-02-06, under 510(k) number K860301.

Who is the listed applicant for RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE?

The FDA 510(k) record lists Carr-Scarborough Microbiologicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE?

The FDA product code for RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE is JTO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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