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FDA 510(k)

NAPHTHYL PHOSPHATE, ACID PHOSPHATASE

K-Number: K863832 · 1986-12-16

ApplicantPointe Scientific, Inc.,
Decision Date1986-12-16
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NAPHTHYL PHOSPHATE, ACID PHOSPHATASE is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1986-12-16 under 510(k) number K863832. 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 NAPHTHYL PHOSPHATE, ACID PHOSPHATASE?

NAPHTHYL PHOSPHATE, ACID PHOSPHATASE is a medical device that received FDA 510(k) clearance on 1986-12-16. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K863832.

When did NAPHTHYL PHOSPHATE, ACID PHOSPHATASE receive FDA 510(k) clearance?

NAPHTHYL PHOSPHATE, ACID PHOSPHATASE received FDA 510(k) clearance on 1986-12-16, under 510(k) number K863832.

Who is the listed applicant for NAPHTHYL PHOSPHATE, ACID PHOSPHATASE?

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

What is the FDA product code for NAPHTHYL PHOSPHATE, ACID PHOSPHATASE?

The FDA product code for NAPHTHYL PHOSPHATE, ACID PHOSPHATASE is JFH.

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Other records listing Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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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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