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FDA 510(k)

CONTROL 282

K-Number: K832066 · 1983-09-29

ApplicantBio-Nustics, Inc.
Decision Date1983-09-29
Product CodeJKS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CONTROL 282 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Nustics, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832066. The device is classified under product code JKS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROL 282?

CONTROL 282 is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Bio-Nustics, Inc.. The 510(k) number is K832066.

When did CONTROL 282 receive FDA 510(k) clearance?

CONTROL 282 received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832066.

Who is the listed applicant for CONTROL 282?

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

What is the FDA product code for CONTROL 282?

The FDA product code for CONTROL 282 is JKS.

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Related Devices (Code: JKS)

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.

K951485AVOXIMETER 4000A-Vox Systems, Inc.K863825CO-OXIMETER SOLUTIONSD.R.G. Scientific IndustriesK862253IL 482 CO-OXIMETERInstrumentation Laboratory COK853990OSM3 HEMOXIMETERRadiometer America, Inc.K833693TEE ADAPTER 9890-FLUSH WINDING 282Shaban Mfg. Co.K833211BILE SALTS MIXTUREAcumedia Manufacturers, 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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