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FDA 510(k)

BETA SCAN NORMAL CONTROL SOLUTION

K-Number: K831523 · 1983-07-19

ApplicantOrange Medical Instruments, Inc.
Decision Date1983-07-19
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETA SCAN NORMAL CONTROL SOLUTION 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 1983-07-19 under 510(k) number K831523. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA SCAN NORMAL CONTROL SOLUTION?

BETA SCAN NORMAL CONTROL SOLUTION is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Orange Medical Instruments, Inc.. The 510(k) number is K831523.

When did BETA SCAN NORMAL CONTROL SOLUTION receive FDA 510(k) clearance?

BETA SCAN NORMAL CONTROL SOLUTION received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831523.

Who is the listed applicant for BETA SCAN NORMAL CONTROL SOLUTION?

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 NORMAL CONTROL SOLUTION?

The FDA product code for BETA SCAN NORMAL CONTROL SOLUTION is JJX.

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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 LANCETK841369BETA SCAN DRYSTIXK833705BETAJECT BD U100

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Related Devices (Code: JJX)

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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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