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FDA 510(k)

RIAPHASE (125I) PROST. ACID PHOSPH. KIT

K-Number: K803043 · 1981-01-02

ApplicantBeckman Instruments, Inc.
Decision Date1981-01-02
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIAPHASE (125I) PROST. ACID PHOSPH. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1981-01-02 under 510(k) number K803043. The device is classified under product code JFH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIAPHASE (125I) PROST. ACID PHOSPH. KIT?

RIAPHASE (125I) PROST. ACID PHOSPH. KIT is a medical device that received FDA 510(k) clearance on 1981-01-02. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K803043.

When did RIAPHASE (125I) PROST. ACID PHOSPH. KIT receive FDA 510(k) clearance?

RIAPHASE (125I) PROST. ACID PHOSPH. KIT received FDA 510(k) clearance on 1981-01-02, under 510(k) number K803043.

Who is the listed applicant for RIAPHASE (125I) PROST. ACID PHOSPH. KIT?

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

What is the FDA product code for RIAPHASE (125I) PROST. ACID PHOSPH. KIT?

The FDA product code for RIAPHASE (125I) PROST. ACID PHOSPH. KIT is JFH.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: JFH)

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.

K000257IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6Diagnostic Products Corp.K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEUnited Biotech, Inc.K964756PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KITWano-Tech Corp.K931701IMMULITE PAPDiagnostic Products Corp.K925377IMX PAPAbbott LaboratoriesK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOHybritech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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