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FDA 510(k)

IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6

K-Number: K993251 · 1999-11-17

ApplicantDiagnostic Products Corp.
Decision Date1999-11-17
Product CodeLIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 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 1999-11-17 under 510(k) number K993251. The device is classified under product code LIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6?

IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 is a medical device that received FDA 510(k) clearance on 1999-11-17. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K993251.

When did IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 receive FDA 510(k) clearance?

IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 received FDA 510(k) clearance on 1999-11-17, under 510(k) number K993251.

Who is the listed applicant for IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6?

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 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6?

The FDA product code for IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 is LIG.

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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: LIG)

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.

K240800Access Intrinsic Factor AbBeckman Coulter, Inc.K071346IMMULISA INTRINSIC FACTOR ANTIBODY ELISAImmco Diagnostics, Inc.K061841QUANTA LITE INTRINSIC FACTOR ELISAInova Diagnostics, Inc.K033603INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999Beckman Coulter, Inc.K984108ABBOTT ARCHITECT B12Abbott LaboratoriesK903218IMX B12Abbott 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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