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FDA 510(k)

IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ

K-Number: K963695 · 1997-01-17

ApplicantDiagnostic Products Corp.
Decision Date1997-01-17
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ 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 1997-01-17 under 510(k) number K963695. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ?

IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K963695.

When did IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ receive FDA 510(k) clearance?

IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ received FDA 510(k) clearance on 1997-01-17, under 510(k) number K963695.

Who is the listed applicant for IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ?

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 ANTI-TPO-AB(LKTOI,LKT05,LKTOZ?

The FDA product code for IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ is JZO.

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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: JZO)

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.

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB

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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