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FDA 510(k)

CELL-MATICS HERPES SIMPLEX VIRUS DETECT

K-Number: K840366 · 1985-01-08

ApplicantDifco Laboratories, Inc.
Decision Date1985-01-08
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-MATICS HERPES SIMPLEX VIRUS DETECT 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 1985-01-08 under 510(k) number K840366. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL-MATICS HERPES SIMPLEX VIRUS DETECT?

CELL-MATICS HERPES SIMPLEX VIRUS DETECT is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K840366.

When did CELL-MATICS HERPES SIMPLEX VIRUS DETECT receive FDA 510(k) clearance?

CELL-MATICS HERPES SIMPLEX VIRUS DETECT received FDA 510(k) clearance on 1985-01-08, under 510(k) number K840366.

Who is the listed applicant for CELL-MATICS HERPES SIMPLEX VIRUS DETECT?

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 CELL-MATICS HERPES SIMPLEX VIRUS DETECT?

The FDA product code for CELL-MATICS HERPES SIMPLEX VIRUS DETECT is KIR.

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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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