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FDA 510(k)

ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)

K-Number: K021257 · 2002-06-03

ApplicantDiagnostic Products Corp.
Decision Date2002-06-03
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) 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 2002-06-03 under 510(k) number K021257. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)?

ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) is a medical device that received FDA 510(k) clearance on 2002-06-03. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K021257.

When did ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) receive FDA 510(k) clearance?

ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) received FDA 510(k) clearance on 2002-06-03, under 510(k) number K021257.

Who is the listed applicant for ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)?

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 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)?

The FDA product code for ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) is LKJ.

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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: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, 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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