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FDA 510(k)

G-GT STANDARD CALIBRATOR

K-Number: K871759 · 1987-09-29

ApplicantWako Chemicals USA, Inc.
Decision Date1987-09-29
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

G-GT STANDARD CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Wako Chemicals USA, Inc.. It received FDA 510(k) clearance on 1987-09-29 under 510(k) number K871759. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-GT STANDARD CALIBRATOR?

G-GT STANDARD CALIBRATOR is a medical device that received FDA 510(k) clearance on 1987-09-29. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K871759.

When did G-GT STANDARD CALIBRATOR receive FDA 510(k) clearance?

G-GT STANDARD CALIBRATOR received FDA 510(k) clearance on 1987-09-29, under 510(k) number K871759.

Who is the listed applicant for G-GT STANDARD CALIBRATOR?

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

What is the FDA product code for G-GT STANDARD CALIBRATOR?

The FDA product code for G-GT STANDARD CALIBRATOR is JIT.

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Other records listing Wako Chemicals USA, 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.

K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONK080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201K080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATORK062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191

View all 123 devices →

Related Devices (Code: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio 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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