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FDA 510(k)

GENTAMICIN (FPIA) CALIBRATOR KIT

K-Number: K861769 · 1986-06-25

ApplicantWindsor Laboratories, Inc.
Decision Date1986-06-25
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN (FPIA) CALIBRATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Laboratories, Inc.. It received FDA 510(k) clearance on 1986-06-25 under 510(k) number K861769. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN (FPIA) CALIBRATOR KIT?

GENTAMICIN (FPIA) CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 1986-06-25. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K861769.

When did GENTAMICIN (FPIA) CALIBRATOR KIT receive FDA 510(k) clearance?

GENTAMICIN (FPIA) CALIBRATOR KIT received FDA 510(k) clearance on 1986-06-25, under 510(k) number K861769.

Who is the listed applicant for GENTAMICIN (FPIA) CALIBRATOR KIT?

The FDA 510(k) record lists Windsor Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENTAMICIN (FPIA) CALIBRATOR KIT?

The FDA product code for GENTAMICIN (FPIA) CALIBRATOR KIT is JIS.

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Other records listing Windsor Laboratories, Inc. 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.

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITK873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYK871486(FPIA) ASSAY BUFFERK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK870389DIGOXIN (FPIA) CALIBRATOR KITK864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

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Related Devices (Code: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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