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FDA 510(k)

FLUOROSKAN

K-Number: K842049 · 1984-12-03

ApplicantFlow Laboratories, Inc.
Decision Date1984-12-03
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLUOROSKAN 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 1984-12-03 under 510(k) number K842049. The device is classified under product code JZT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROSKAN?

FLUOROSKAN is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K842049.

When did FLUOROSKAN receive FDA 510(k) clearance?

FLUOROSKAN received FDA 510(k) clearance on 1984-12-03, under 510(k) number K842049.

Who is the listed applicant for FLUOROSKAN?

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 FLUOROSKAN?

The FDA product code for FLUOROSKAN is JZT.

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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: JZT)

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.

K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERBartels, Inc.K883349QLIA IMMUNOCHEMISTRY SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK882677STAT-20 FLUOROMETERWeaver MedicalK864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)Pandex Laboratories, Inc.K863434THE FIAX 5000 FLUOROMETERWhittaker Bioproducts, Inc.K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMHybritech, 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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