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FDA 510(k)

COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT

K-Number: K891167 · 1989-05-03

ApplicantDiagnostic Products Corp.
Decision Date1989-05-03
Product CodeDLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT 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 1989-05-03 under 510(k) number K891167. The device is classified under product code DLB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT?

COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1989-05-03. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K891167.

When did COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1989-05-03, under 510(k) number K891167.

Who is the listed applicant for COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT?

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(TM) LSD RADIOIMMUNOASSAY KIT?

The FDA product code for COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT is DLB.

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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

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Related Devices (Code: DLB)

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.

K961436ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)Roche Diagnostic Systems, Inc.K955448EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLSBehring Diagnostics, Inc.K955814CEDIA DAU LSD ASSAYMicrogenics Corp.K954073STC DIAGNOSTICS LSD MICRO-PLATE EIASolarcare Technologies Corp,Inc.K874270REVISED LABELING FOR LSD TEST KITRoche Diagnostic Systems, Inc.K860525ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARDRoche Diagnostic Systems, 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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