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FDA 510(k)

IMMULON REMOVAWELL STRIPS #011-010-6301

K-Number: K802857 · 1980-12-11

ApplicantDynatech Corp.
Decision Date1980-12-11
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMULON REMOVAWELL STRIPS #011-010-6301 is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Corp.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802857. The device is classified under product code JTC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULON REMOVAWELL STRIPS #011-010-6301?

IMMULON REMOVAWELL STRIPS #011-010-6301 is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Dynatech Corp.. The 510(k) number is K802857.

When did IMMULON REMOVAWELL STRIPS #011-010-6301 receive FDA 510(k) clearance?

IMMULON REMOVAWELL STRIPS #011-010-6301 received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802857.

Who is the listed applicant for IMMULON REMOVAWELL STRIPS #011-010-6301?

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 REMOVAWELL STRIPS #011-010-6301?

The FDA product code for IMMULON REMOVAWELL STRIPS #011-010-6301 is JTC.

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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 READERK854604AUTO MASHK854602MINI MASH 2000K854603MULTI MASH 2000K832117IMMULON SUBSTRATE REMOVAWELL STRIPSK823787HANDI-WASH

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Related Devices (Code: JTC)

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.

K924907FILTERMATE UNIVERSAL HARVESTERPackard Instrument Co., Inc.K901808MICROMATE 196 MODEL A961960Packard Instrument Co., Inc.K894645IMMULON 1,2,3,AND 4 DIVIDASTRIPS TMDynatech Laboratories, Inc.K892369MULTI-PROBE HEAD PLUSHamilton Co.K891766GENETIC SYSTEMS MICROPLATE STRIP WASHERGenetic Systems Corp.K891765GENETIC SYSTEMS PIPETTOR/DILUTORGenetic Systems Corp.

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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