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FDA 510(k)

MDT CASTLE BIOSIGN TEST PACK

K-Number: K922212 · 1992-08-10

ApplicantMdt Corp., Inc.
Decision Date1992-08-10
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MDT CASTLE BIOSIGN TEST PACK is the device name listed in this FDA 510(k) record. The listed applicant is Mdt Corp., Inc.. It received FDA 510(k) clearance on 1992-08-10 under 510(k) number K922212. 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 MDT CASTLE BIOSIGN TEST PACK?

MDT CASTLE BIOSIGN TEST PACK is a medical device that received FDA 510(k) clearance on 1992-08-10. The listed applicant is Mdt Corp., Inc.. The 510(k) number is K922212.

When did MDT CASTLE BIOSIGN TEST PACK receive FDA 510(k) clearance?

MDT CASTLE BIOSIGN TEST PACK received FDA 510(k) clearance on 1992-08-10, under 510(k) number K922212.

Who is the listed applicant for MDT CASTLE BIOSIGN TEST PACK?

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

What is the FDA product code for MDT CASTLE BIOSIGN TEST PACK?

The FDA product code for MDT CASTLE BIOSIGN TEST PACK is FRC.

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Other records listing Mdt Corp., 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.

K960777MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATORK942485MDT UROLOGY TABLEK942486IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLEK924380MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVEK926081DENTAL LIGHTK924955MDT/HARVEY MC-8 AND MC-10

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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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