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FDA 510(k)

SERACULT OCCULT BLOOF TEST

K-Number: K813204 · 1982-01-28

ApplicantPropper Mfg. Co., Inc.
Decision Date1982-01-28
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SERACULT OCCULT BLOOF TEST 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 1982-01-28 under 510(k) number K813204. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERACULT OCCULT BLOOF TEST?

SERACULT OCCULT BLOOF TEST is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is Propper Mfg. Co., Inc.. The 510(k) number is K813204.

When did SERACULT OCCULT BLOOF TEST receive FDA 510(k) clearance?

SERACULT OCCULT BLOOF TEST received FDA 510(k) clearance on 1982-01-28, under 510(k) number K813204.

Who is the listed applicant for SERACULT OCCULT BLOOF TEST?

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 SERACULT OCCULT BLOOF TEST?

The FDA product code for SERACULT OCCULT BLOOF TEST is KHE.

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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: KHE)

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.

K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.K170548InSure ONEEnterix, Inc.K171484hema-screen SPECIFIC GoldImmunostics Inc.,K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI Diagnostics, LLC

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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