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FDA 510(k)

LEECO P.A.P. QUANT. DIAGNOSTIC KIT

K-Number: K792652 · 1980-01-16

ApplicantLeeco Diagnostics, Inc.
Decision Date1980-01-16
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO P.A.P. QUANT. DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-01-16 under 510(k) number K792652. 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 LEECO P.A.P. QUANT. DIAGNOSTIC KIT?

LEECO P.A.P. QUANT. DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K792652.

When did LEECO P.A.P. QUANT. DIAGNOSTIC KIT receive FDA 510(k) clearance?

LEECO P.A.P. QUANT. DIAGNOSTIC KIT received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792652.

Who is the listed applicant for LEECO P.A.P. QUANT. DIAGNOSTIC KIT?

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

What is the FDA product code for LEECO P.A.P. QUANT. DIAGNOSTIC KIT?

The FDA product code for LEECO P.A.P. QUANT. DIAGNOSTIC KIT is JFH.

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Other records listing Leeco Diagnostics, 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.

K895765LEECO PREVIEW(R) EBV (EIA)K894122LEECO VIS-DISK STREP-A (EIA)K891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MK891096VIS-DISK HCG (EIA) JPL-041MK883269PRL-QUANTK880577CONCEP-7-BHCG

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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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