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FDA 510(k)

IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5

K-Number: K980833 · 1998-05-01

ApplicantDiagnostic Products Corp.
Decision Date1998-05-01
Product CodeJMM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 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 1998-05-01 under 510(k) number K980833. The device is classified under product code JMM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5?

IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K980833.

When did IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 receive FDA 510(k) clearance?

IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 received FDA 510(k) clearance on 1998-05-01, under 510(k) number K980833.

Who is the listed applicant for IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5?

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 PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5?

The FDA product code for IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 is JMM.

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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: JMM)

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.

K011052OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USEOstex Intl., Inc.K993706ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAYRoche Diagnostics Corp.K992997OSTEOMARK NTX POCMetrika, Inc.K990843SERUM CROSSLAPS ONE STEP ELISAOsteometer Biotech A/SK983457OSTEOMARK NTX SERUM EIAOstex Intl., Inc.K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSOrtho-Clinical Diagnostics, 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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