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FDA 510(k)

IMMULITE PAP

K-Number: K931701 · 1994-01-27

ApplicantDiagnostic Products Corp.
Decision Date1994-01-27
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE PAP is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1994-01-27 under 510(k) number K931701. 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 IMMULITE PAP?

IMMULITE PAP is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K931701.

When did IMMULITE PAP receive FDA 510(k) clearance?

IMMULITE PAP received FDA 510(k) clearance on 1994-01-27, under 510(k) number K931701.

Who is the listed applicant for IMMULITE PAP?

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

What is the FDA product code for IMMULITE PAP?

The FDA product code for IMMULITE PAP 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 Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 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.K925377IMX PAPAbbott LaboratoriesK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOHybritech, Inc.K902937MILENIA PAP IRMA CATALOG #: MKPA1, XDiagnostic Products Corp.

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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