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FDA 510(k)

TITERTEK TWINREADER 78-630-00

K-Number: K844567 · 1985-03-21

ApplicantFlow Laboratories, Inc.
Decision Date1985-03-21
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TITERTEK TWINREADER 78-630-00 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 1985-03-21 under 510(k) number K844567. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITERTEK TWINREADER 78-630-00?

TITERTEK TWINREADER 78-630-00 is a medical device that received FDA 510(k) clearance on 1985-03-21. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K844567.

When did TITERTEK TWINREADER 78-630-00 receive FDA 510(k) clearance?

TITERTEK TWINREADER 78-630-00 received FDA 510(k) clearance on 1985-03-21, under 510(k) number K844567.

Who is the listed applicant for TITERTEK TWINREADER 78-630-00?

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 TWINREADER 78-630-00?

The FDA product code for TITERTEK TWINREADER 78-630-00 is JJQ.

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Other records listing Flow Laboratories, Inc. as applicant

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K861897UNISKAN IIK862066TITERTEK MICROPLATE WASHER S-12K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)K861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEK860762GAMMA-FREE HORSE SERUM

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Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, Inc.

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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