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FDA 510(k)

CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)

K-Number: K861080 · 1986-04-07

ApplicantDifco Laboratories, Inc.
Decision Date1986-04-07
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI) is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K861080. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)?

CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI) is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K861080.

When did CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI) receive FDA 510(k) clearance?

CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI) received FDA 510(k) clearance on 1986-04-07, under 510(k) number K861080.

Who is the listed applicant for CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)?

The FDA 510(k) record lists Difco Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)?

The FDA product code for CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI) is JSM.

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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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