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FDA 510(k)

DSL PAP RIA -DSL#3100

K-Number: K844679 · 1985-04-29

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1985-04-29
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL PAP RIA -DSL#3100 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K844679. 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 DSL PAP RIA -DSL#3100?

DSL PAP RIA -DSL#3100 is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K844679.

When did DSL PAP RIA -DSL#3100 receive FDA 510(k) clearance?

DSL PAP RIA -DSL#3100 received FDA 510(k) clearance on 1985-04-29, under 510(k) number K844679.

Who is the listed applicant for DSL PAP RIA -DSL#3100?

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

What is the FDA product code for DSL PAP RIA -DSL#3100?

The FDA product code for DSL PAP RIA -DSL#3100 is JFH.

Other records listing Diagnostic Systems 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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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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