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FDA 510(k)

LBI-100 37DEGREES INCUBATOR

K-Number: K830405 · 1983-03-10

ApplicantBionetic Laboratory Products
Decision Date1983-03-10
Product CodeJTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LBI-100 37DEGREES INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bionetic Laboratory Products. It received FDA 510(k) clearance on 1983-03-10 under 510(k) number K830405. The device is classified under product code JTQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LBI-100 37DEGREES INCUBATOR?

LBI-100 37DEGREES INCUBATOR is a medical device that received FDA 510(k) clearance on 1983-03-10. The listed applicant is Bionetic Laboratory Products. The 510(k) number is K830405.

When did LBI-100 37DEGREES INCUBATOR receive FDA 510(k) clearance?

LBI-100 37DEGREES INCUBATOR received FDA 510(k) clearance on 1983-03-10, under 510(k) number K830405.

Who is the listed applicant for LBI-100 37DEGREES INCUBATOR?

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

What is the FDA product code for LBI-100 37DEGREES INCUBATOR?

The FDA product code for LBI-100 37DEGREES INCUBATOR is JTQ.

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Other records listing Bionetic Laboratory Products 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.

K833637VZV BIO-ENZABEAD SCREEN KITK832900IMMUNOENZYME TEST SYS-DETECT-IGM ANTIK832069TOXO IPA KIT IAN INDIRECT FLUORESCENTK831760LEGIONELLA IFA KIT IK831133AMEBIASIS BIO-ENZABEAD SCREEN KITK830820LEGIONELLA DFA KIT I

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Related Devices (Code: JTQ)

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.

K875275WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMERSterling Drug, Inc.K853379PLATE INCUBATORScientific Sales Intl., Inc.K831592ANHYDRIC INCUBATORS, CULTURE INCUBATORBoekel Industries, Inc.K830322C.A.T. REAGENT KITRemel Co.K830227AUTOMATED ELISA READER LBI 300Bionetic Laboratory ProductsK822564WATER BATHBoekel Industries, 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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