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FDA 510(k)

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2

K-Number: K901933 · 1990-06-28

ApplicantDiagnostic Products Corp.
Decision Date1990-06-28
Product CodeJFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 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 1990-06-28 under 510(k) number K901933. 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 COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2?

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K901933.

When did COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 receive FDA 510(k) clearance?

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 received FDA 510(k) clearance on 1990-06-28, under 510(k) number K901933.

Who is the listed applicant for COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2?

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 COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2?

The FDA product code for COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 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.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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