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FDA 510(k)

SPECIMEN COLLECTOR

K-Number: K770112 · 1977-03-14

ApplicantPortex, Inc.
Decision Date1977-03-14
Product CodeFMH
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SPECIMEN COLLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Portex, Inc.. It received FDA 510(k) clearance on 1977-03-14 under 510(k) number K770112. The device is classified under product code FMH. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECIMEN COLLECTOR?

SPECIMEN COLLECTOR is a medical device that received FDA 510(k) clearance on 1977-03-14. The listed applicant is Portex, Inc.. The 510(k) number is K770112.

When did SPECIMEN COLLECTOR receive FDA 510(k) clearance?

SPECIMEN COLLECTOR received FDA 510(k) clearance on 1977-03-14, under 510(k) number K770112.

Who is the listed applicant for SPECIMEN COLLECTOR?

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

What is the FDA product code for SPECIMEN COLLECTOR?

The FDA product code for SPECIMEN COLLECTOR is FMH.

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Other records listing Portex, 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.

K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERK031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITK0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORK0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXK014073HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICEK873992LARYNGECTOMY TUBE

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Related Devices (Code: FMH)

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.

K900983TRI-TECH URINE SPECIMEN KITTri-Tech, Inc.K823763VARIOUS-SPECIMEN COLLECTORSCordis Corp.K820180CALCULI FILTER CUPOmnimedicalK812933LANCER SPECIMEN CONTAINERSherwood Medical Co.K802340SPECIMEN SETAmerican Pharmaseal Div. AhscK802002URINE SPECIMEN CONTAINER #'S 1013-1016Pollak (Intl.), Ltd.

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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