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FDA 510(k)

SOPHEIA DIGITOXIN EIA KIT & COMPONENTS

K-Number: K830035 · 1983-01-28

ApplicantDiagnostic Products Corp.
Decision Date1983-01-28
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SOPHEIA DIGITOXIN EIA KIT & COMPONENTS 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 1983-01-28 under 510(k) number K830035. The device is classified under product code LFM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPHEIA DIGITOXIN EIA KIT & COMPONENTS?

SOPHEIA DIGITOXIN EIA KIT & COMPONENTS is a medical device that received FDA 510(k) clearance on 1983-01-28. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K830035.

When did SOPHEIA DIGITOXIN EIA KIT & COMPONENTS receive FDA 510(k) clearance?

SOPHEIA DIGITOXIN EIA KIT & COMPONENTS received FDA 510(k) clearance on 1983-01-28, under 510(k) number K830035.

Who is the listed applicant for SOPHEIA DIGITOXIN EIA KIT & COMPONENTS?

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 SOPHEIA DIGITOXIN EIA KIT & COMPONENTS?

The FDA product code for SOPHEIA DIGITOXIN EIA KIT & COMPONENTS is LFM.

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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: LFM)

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.

K062024DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGEDade Behring, Inc.K012112RANDOX DIGITOXINRandox Laboratories, Ltd.K990251DGTX FLEX REAGENT CARTRIDGE, MODEL DF36Dade Behring, Inc.K970546ACS DIGITOXINChiron Diagnostics Corp.K963158ABBOTT AXSYM DIGITOXIN (MODIFY)Abbott LaboratoriesK954420AXSYM DIGITOXINAbbott Laboratories

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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