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FDA 510(k)

ARMTROL AND FERMTROL

K-Number: K780802 · 1978-06-13

ApplicantBiotron , Ltd.
Decision Date1978-06-13
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARMTROL AND FERMTROL is the device name listed in this FDA 510(k) record. The listed applicant is Biotron , Ltd.. It received FDA 510(k) clearance on 1978-06-13 under 510(k) number K780802. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARMTROL AND FERMTROL?

ARMTROL AND FERMTROL is a medical device that received FDA 510(k) clearance on 1978-06-13. The listed applicant is Biotron , Ltd.. The 510(k) number is K780802.

When did ARMTROL AND FERMTROL receive FDA 510(k) clearance?

ARMTROL AND FERMTROL received FDA 510(k) clearance on 1978-06-13, under 510(k) number K780802.

Who is the listed applicant for ARMTROL AND FERMTROL?

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

What is the FDA product code for ARMTROL AND FERMTROL?

The FDA product code for ARMTROL AND FERMTROL is JJW.

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Other records listing Biotron , Ltd. 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.

K910135THE UNIVERSAL CEMENT PLUG(TM)K843583FIRM-A-TRON MARK XK810634FIRM-A-TRONK780803TILL-U-TEST, DIP SLIDE

Related Devices (Code: JJW)

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.

K170091UA-Cellular CompleteStreckK110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories LimitedK103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa CorporationK072640IRISPEC,CA/CB/CCIris DiagnosticsK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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