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FDA 510(k)

RIAGEN PAP RIA

K-Number: K813261 · 1981-12-17

ApplicantBiogenex Laboratories
Decision Date1981-12-17
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIAGEN PAP RIA is the device name listed in this FDA 510(k) record. The listed applicant is Biogenex Laboratories. It received FDA 510(k) clearance on 1981-12-17 under 510(k) number K813261. 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 RIAGEN PAP RIA?

RIAGEN PAP RIA is a medical device that received FDA 510(k) clearance on 1981-12-17. The listed applicant is Biogenex Laboratories. The 510(k) number is K813261.

When did RIAGEN PAP RIA receive FDA 510(k) clearance?

RIAGEN PAP RIA received FDA 510(k) clearance on 1981-12-17, under 510(k) number K813261.

Who is the listed applicant for RIAGEN PAP RIA?

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

What is the FDA product code for RIAGEN PAP RIA?

The FDA product code for RIAGEN PAP RIA is JFH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biogenex Laboratories 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.

K012960BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORK013148BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)K925189PREGNAGEN 1-STEP PREGNANCY TESTK902208MODIFIED OVUGENK884880PREGNAGEN(TM)K882002PREGNAGEN(TM)

View all 12 devices →

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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