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FDA 510(k)

DADE RH CONTROL REAGENT

K-Number: K810599 · 1981-03-31

ApplicantAmerican Dade
Decision Date1981-03-31
Product CodeKSF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE RH CONTROL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-03-31 under 510(k) number K810599. The device is classified under product code KSF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE RH CONTROL REAGENT?

DADE RH CONTROL REAGENT is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is American Dade. The 510(k) number is K810599.

When did DADE RH CONTROL REAGENT receive FDA 510(k) clearance?

DADE RH CONTROL REAGENT received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810599.

Who is the listed applicant for DADE RH CONTROL REAGENT?

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

What is the FDA product code for DADE RH CONTROL REAGENT?

The FDA product code for DADE RH CONTROL REAGENT is KSF.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

Related Devices (Code: KSF)

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.

K811713AVI-D CONTROLOrtho Diagnostic Systems, Inc.K801425RH CONTROLNorth American Biologicals, Inc.K800658RST-SERIES CONTROLGamma Biologicals, Inc.K800310ORTHO ANTISERA CONTROLOrtho Diagnostics, Inc.K800239RH-HR NEGATIVE CONTROL REAGENTGotham Biologics, Inc.K790249TEST CELLSHyland Therapeutic Div., Travenol Laboratories

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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