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FDA 510(k)

QUALIFY I & II AMER. MONITOR 2009 & 2010

K-Number: K843611 · 1984-09-28

ApplicantAmerican Monitor Corp.
Decision Date1984-09-28
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUALIFY I & II AMER. MONITOR 2009 & 2010 is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1984-09-28 under 510(k) number K843611. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALIFY I & II AMER. MONITOR 2009 & 2010?

QUALIFY I & II AMER. MONITOR 2009 & 2010 is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is American Monitor Corp.. The 510(k) number is K843611.

When did QUALIFY I & II AMER. MONITOR 2009 & 2010 receive FDA 510(k) clearance?

QUALIFY I & II AMER. MONITOR 2009 & 2010 received FDA 510(k) clearance on 1984-09-28, under 510(k) number K843611.

Who is the listed applicant for QUALIFY I & II AMER. MONITOR 2009 & 2010?

The FDA 510(k) record lists American Monitor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUALIFY I & II AMER. MONITOR 2009 & 2010?

The FDA product code for QUALIFY I & II AMER. MONITOR 2009 & 2010 is JJY.

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Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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Related Devices (Code: JJY)

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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