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FDA 510(k)

SOPHEIA GENTAMICIN EIA KIT

K-Number: K823387 · 1982-12-22

ApplicantDiagnostic Products Corp.
Decision Date1982-12-22
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SOPHEIA GENTAMICIN EIA 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 1982-12-22 under 510(k) number K823387. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPHEIA GENTAMICIN EIA KIT?

SOPHEIA GENTAMICIN EIA KIT is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K823387.

When did SOPHEIA GENTAMICIN EIA KIT receive FDA 510(k) clearance?

SOPHEIA GENTAMICIN EIA KIT received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823387.

Who is the listed applicant for SOPHEIA GENTAMICIN EIA 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 SOPHEIA GENTAMICIN EIA KIT?

The FDA product code for SOPHEIA GENTAMICIN EIA KIT is LCD.

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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: LCD)

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.

K243500ARCHITECT iGentamicinAbbott LaboratoriesK102699ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSAbbott LaboratoriesK060709MULTIGENT GENTAMICINSeradyn, Inc.K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHEOrtho-Clinical Diagnostics, Inc.K020704ROCHE ONLINE GENTAMICINRoche Diagnostics Corp.K012978RANDOX GENTAMICINRandox Laboratories, Ltd.

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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