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FDA 510(k)

BETA SCAN DRYSTIX

K-Number: K841369 · 1984-08-23

ApplicantOrange Medical Instruments, Inc.
Decision Date1984-08-23
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETA SCAN DRYSTIX is the device name listed in this FDA 510(k) record. The listed applicant is Orange Medical Instruments, Inc.. It received FDA 510(k) clearance on 1984-08-23 under 510(k) number K841369. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA SCAN DRYSTIX?

BETA SCAN DRYSTIX is a medical device that received FDA 510(k) clearance on 1984-08-23. The listed applicant is Orange Medical Instruments, Inc.. The 510(k) number is K841369.

When did BETA SCAN DRYSTIX receive FDA 510(k) clearance?

BETA SCAN DRYSTIX received FDA 510(k) clearance on 1984-08-23, under 510(k) number K841369.

Who is the listed applicant for BETA SCAN DRYSTIX?

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

What is the FDA product code for BETA SCAN DRYSTIX?

The FDA product code for BETA SCAN DRYSTIX is CGA.

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Other records listing Orange Medical Instruments, 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.

K860808CONTINUCATHK851822BETA SCAN TRENDS METERK844796MICRO-BETA U100 SYRINGEK843882TRENDS LANCETK833705BETAJECT BD U100K833706CLICK-COUNT U100 INSULIN SYRINGE

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Related Devices (Code: CGA)

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.

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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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