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FDA 510(k)

IMMULITE VITAMIN B12 (LKVB1,LKVB5)

K-Number: K971177 · 1997-05-16

ApplicantDiagnostic Products Corp.
Decision Date1997-05-16
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE VITAMIN B12 (LKVB1,LKVB5) 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 1997-05-16 under 510(k) number K971177. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE VITAMIN B12 (LKVB1,LKVB5)?

IMMULITE VITAMIN B12 (LKVB1,LKVB5) is a medical device that received FDA 510(k) clearance on 1997-05-16. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K971177.

When did IMMULITE VITAMIN B12 (LKVB1,LKVB5) receive FDA 510(k) clearance?

IMMULITE VITAMIN B12 (LKVB1,LKVB5) received FDA 510(k) clearance on 1997-05-16, under 510(k) number K971177.

Who is the listed applicant for IMMULITE VITAMIN B12 (LKVB1,LKVB5)?

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 VITAMIN B12 (LKVB1,LKVB5)?

The FDA product code for IMMULITE VITAMIN B12 (LKVB1,LKVB5) is CDD.

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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

View all 321 devices →

Related Devices (Code: CDD)

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.

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme 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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