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FDA 510(k)

CODE-A-WELL

K-Number: K841390 · 1984-05-02

ApplicantPlastic Injectors, Inc.
Decision Date1984-05-02
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CODE-A-WELL is the device name listed in this FDA 510(k) record. The listed applicant is Plastic Injectors, Inc.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K841390. 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 CODE-A-WELL?

CODE-A-WELL is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Plastic Injectors, Inc.. The 510(k) number is K841390.

When did CODE-A-WELL receive FDA 510(k) clearance?

CODE-A-WELL received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841390.

Who is the listed applicant for CODE-A-WELL?

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

What is the FDA product code for CODE-A-WELL?

The FDA product code for CODE-A-WELL is LIB.

Other records listing Plastic Injectors, 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.

K884781OPTI-POINTK863423CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100K863374CODE-A-WELL SERIES 1-600, 1-625K844058CODE-A-WALL SERIES 1-250 INOCULUM TRAYK842848CODE-A-WELL 350 MICROTITRATION STRIPSK841632CODE-A-WELL SERIES 200 PLATE

View all 8 devices →

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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