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FDA 510(k)

IMMULON SUBSTRATE REMOVAWELL STRIPS

K-Number: K832117 · 1983-08-08

ApplicantDynatech Corp.
Decision Date1983-08-08
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMULON SUBSTRATE REMOVAWELL STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Corp.. It received FDA 510(k) clearance on 1983-08-08 under 510(k) number K832117. The device is classified under product code LIB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULON SUBSTRATE REMOVAWELL STRIPS?

IMMULON SUBSTRATE REMOVAWELL STRIPS is a medical device that received FDA 510(k) clearance on 1983-08-08. The listed applicant is Dynatech Corp.. The 510(k) number is K832117.

When did IMMULON SUBSTRATE REMOVAWELL STRIPS receive FDA 510(k) clearance?

IMMULON SUBSTRATE REMOVAWELL STRIPS received FDA 510(k) clearance on 1983-08-08, under 510(k) number K832117.

Who is the listed applicant for IMMULON SUBSTRATE REMOVAWELL STRIPS?

The FDA 510(k) record lists Dynatech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULON SUBSTRATE REMOVAWELL STRIPS?

The FDA product code for IMMULON SUBSTRATE REMOVAWELL STRIPS is LIB.

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Other records listing Dynatech Corp. 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.

K904567DYNATECH MR4000 MICROPLATE READERK854603MULTI MASH 2000K854602MINI MASH 2000K854604AUTO MASHK823787HANDI-WASHK823833MICRO STIX #011-010-5000 & HOLDER#5100

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Related Devices (Code: LIB)

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.

K023677OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)OsmetechK920416SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMBBehring Diagnostics, Inc.K912558GULL ELISAWAREGull Laboratories, Inc.K872273CORNING EASY WASH ELISA PLATESCorning Medical & ScientificK871559CELL LIFTERCorning Costar Corp.K864249NORMAL SALINE STERILEMds Laboratories, 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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