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FDA 510(k)

MED-PEN/MED-POINT

K-Number: K853733 · 1986-12-04

ApplicantGarid, Inc.
Decision Date1986-12-04
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MED-PEN/MED-POINT is the device name listed in this FDA 510(k) record. The listed applicant is Garid, Inc.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K853733. 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 MED-PEN/MED-POINT?

MED-PEN/MED-POINT is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is Garid, Inc.. The 510(k) number is K853733.

When did MED-PEN/MED-POINT receive FDA 510(k) clearance?

MED-PEN/MED-POINT received FDA 510(k) clearance on 1986-12-04, under 510(k) number K853733.

Who is the listed applicant for MED-PEN/MED-POINT?

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

What is the FDA product code for MED-PEN/MED-POINT?

The FDA product code for MED-PEN/MED-POINT is CGA.

Related Clinical Trials

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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Other records listing Garid, 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.

K872049NOVOCHECK/CHECKPOINT/CONTROL SOLUTION

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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