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FDA 510(k)

IMMULITE THIRD GENERATION (MODIFICATION)

K-Number: K940006 · 1994-12-19

ApplicantDiagnostic Products Corp.
Decision Date1994-12-19
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE THIRD GENERATION (MODIFICATION) 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 1994-12-19 under 510(k) number K940006. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE THIRD GENERATION (MODIFICATION)?

IMMULITE THIRD GENERATION (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1994-12-19. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K940006.

When did IMMULITE THIRD GENERATION (MODIFICATION) receive FDA 510(k) clearance?

IMMULITE THIRD GENERATION (MODIFICATION) received FDA 510(k) clearance on 1994-12-19, under 510(k) number K940006.

Who is the listed applicant for IMMULITE THIRD GENERATION (MODIFICATION)?

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 THIRD GENERATION (MODIFICATION)?

The FDA product code for IMMULITE THIRD GENERATION (MODIFICATION) is JLW.

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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: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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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