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FDA 510(k)

TITERTEK ENTEROBAC*

K-Number: K834090 · 1984-01-13

ApplicantFlow Laboratories, Inc.
Decision Date1984-01-13
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TITERTEK ENTEROBAC* is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K834090. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITERTEK ENTEROBAC*?

TITERTEK ENTEROBAC* is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K834090.

When did TITERTEK ENTEROBAC* receive FDA 510(k) clearance?

TITERTEK ENTEROBAC* received FDA 510(k) clearance on 1984-01-13, under 510(k) number K834090.

Who is the listed applicant for TITERTEK ENTEROBAC*?

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

What is the FDA product code for TITERTEK ENTEROBAC*?

The FDA product code for TITERTEK ENTEROBAC* is JSS.

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Other records listing Flow Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K861897UNISKAN IIK862066TITERTEK MICROPLATE WASHER S-12K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEK861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)K860762GAMMA-FREE HORSE SERUM

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Related Devices (Code: JSS)

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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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