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FDA 510(k)

AMINOGLYCOSIDE (125I) RIA KIT

K-Number: K761157 · 1977-03-01

ApplicantDiagnostic Products Corp.
Decision Date1977-03-01
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMINOGLYCOSIDE (125I) RIA KIT 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 1977-03-01 under 510(k) number K761157. The device is classified under product code DJB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMINOGLYCOSIDE (125I) RIA KIT?

AMINOGLYCOSIDE (125I) RIA KIT is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K761157.

When did AMINOGLYCOSIDE (125I) RIA KIT receive FDA 510(k) clearance?

AMINOGLYCOSIDE (125I) RIA KIT received FDA 510(k) clearance on 1977-03-01, under 510(k) number K761157.

Who is the listed applicant for AMINOGLYCOSIDE (125I) RIA KIT?

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 AMINOGLYCOSIDE (125I) RIA KIT?

The FDA product code for AMINOGLYCOSIDE (125I) RIA KIT is DJB.

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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: DJB)

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.

K832792AMES TDA SISOMICIN TEST-CONTROL SERUMMiles Laboratories, Inc.K831210GENTAMICIN TEST PACK-ACAE.I. Dupont DE Nemours & Co., Inc.K821669AMES TDA GENTAMICIN TESTMiles Laboratories, Inc.K812394MRI GENTAMICIN RIA KITMicroanalytic Research, Inc.K811844COAT-A-COUNT GENTAMICIN RIA KITDiagnostic Products Corp.K800537GAMMA STICK GENTAMICIN RIA KITAlpha Gamma Laboratory

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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