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FDA 510(k)

DISPOSABLE STEAM BIOLOGICAL TEST PACK

K-Number: K852192 · 1985-11-01

ApplicantParke-Davis Co.
Decision Date1985-11-01
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE STEAM BIOLOGICAL TEST PACK is the device name listed in this FDA 510(k) record. The listed applicant is Parke-Davis Co.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K852192. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE STEAM BIOLOGICAL TEST PACK?

DISPOSABLE STEAM BIOLOGICAL TEST PACK is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Parke-Davis Co.. The 510(k) number is K852192.

When did DISPOSABLE STEAM BIOLOGICAL TEST PACK receive FDA 510(k) clearance?

DISPOSABLE STEAM BIOLOGICAL TEST PACK received FDA 510(k) clearance on 1985-11-01, under 510(k) number K852192.

Who is the listed applicant for DISPOSABLE STEAM BIOLOGICAL TEST PACK?

The FDA 510(k) record lists Parke-Davis Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE STEAM BIOLOGICAL TEST PACK?

The FDA product code for DISPOSABLE STEAM BIOLOGICAL TEST PACK is FRC.

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Other records listing Parke-Davis Co. 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.

K861725INTRACATH INTRAVENOUS CATHETER PLACEMENT UNITK862119DESERET FLO-THRU INJECTATE TEMPERATURE SENSORK855120ATI DISPOSABLE BIOLOGICAL TEST PACKK860570ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICEK860290VIAPIC CENTRAL LINE CATHETERK841967DESERET THERMODILUTION CARDIAC OUTPUT

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Related Devices (Code: FRC)

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.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK250061Celerity IncubatorSTERIS Corporation

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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