FDA 510(k)

E.COLI 0157 LATEX TEST

K-Number: K944421 · 1994-12-15

Decision Date1994-12-15

Product CodeGMZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

E.COLI 0157 LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab Diagnostics. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K944421. The device is classified under product code GMZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E.COLI 0157 LATEX TEST?

E.COLI 0157 LATEX TEST is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Pro-Lab Diagnostics. The 510(k) number is K944421.

When did E.COLI 0157 LATEX TEST receive FDA 510(k) clearance?

E.COLI 0157 LATEX TEST received FDA 510(k) clearance on 1994-12-15, under 510(k) number K944421.

Who is the listed applicant for E.COLI 0157 LATEX TEST?

The FDA 510(k) record lists Pro-Lab Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E.COLI 0157 LATEX TEST?

The FDA product code for E.COLI 0157 LATEX TEST is GMZ.

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Other records listing Pro-Lab Diagnostics as applicant

K924331TRANSYSTEM LIQUID STUART MEDIUM K924328TRANSYSTEM LIQUID AMIES MEDIUM K924330TRANSYSTEM AMIES WITH CHARCOAL K924329TRANSYSTEM AMIES W/O CHARCOAL

Related Devices (Code: GMZ)

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Official Source

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