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FDA 510(k)

DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI

K-Number: K822298 · 1982-09-02

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1982-09-02
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1982-09-02 under 510(k) number K822298. 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 DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI?

DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI is a medical device that received FDA 510(k) clearance on 1982-09-02. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K822298.

When did DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI receive FDA 510(k) clearance?

DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI received FDA 510(k) clearance on 1982-09-02, under 510(k) number K822298.

Who is the listed applicant for DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI?

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

What is the FDA product code for DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI?

The FDA product code for DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI is JFH.

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Other records listing Nuclear Medical Laboratories, 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.

K852438NML TSH IRMAK844583TSH-STATK840466NML CORTISOL RIAK840589TRI-TUBE RIAK832892MODIFIED CHORIO-SHUREK832002NML-5010/5020 MULTI-DETECTOR SYSTEM

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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

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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