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FDA 510(k)

BI-O.K. STEAM TEST-PAK

K-Number: K903024 · 1990-09-12

ApplicantPropper Mfg. Co., Inc.
Decision Date1990-09-12
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BI-O.K. STEAM TEST-PAK is the device name listed in this FDA 510(k) record. The listed applicant is Propper Mfg. Co., Inc.. It received FDA 510(k) clearance on 1990-09-12 under 510(k) number K903024. 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 BI-O.K. STEAM TEST-PAK?

BI-O.K. STEAM TEST-PAK is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is Propper Mfg. Co., Inc.. The 510(k) number is K903024.

When did BI-O.K. STEAM TEST-PAK receive FDA 510(k) clearance?

BI-O.K. STEAM TEST-PAK received FDA 510(k) clearance on 1990-09-12, under 510(k) number K903024.

Who is the listed applicant for BI-O.K. STEAM TEST-PAK?

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

What is the FDA product code for BI-O.K. STEAM TEST-PAK?

The FDA product code for BI-O.K. STEAM TEST-PAK is FRC.

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Other records listing Propper Mfg. Co., 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.

K111453STEAM DOT BLU PROCESS INDICATORK102894CLASSIX CHEMICAL STERILIZATION INDICATORK082620ONCE-A-DAY VERTOS TEST PACKK031152PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)K991618BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATORK991276PASS/FAIL CHALLENGE PACK

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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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