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FDA 510(k)

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR

K-Number: K970396 · 1997-02-20

ApplicantDade Chemistry Systems, Inc.
Decision Date1997-02-20
Product CodeJIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dade Chemistry Systems, Inc.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K970396. The device is classified under product code JIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN CHORIONIC GONADOTROPIN CALIBRATOR?

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Dade Chemistry Systems, Inc.. The 510(k) number is K970396.

When did HUMAN CHORIONIC GONADOTROPIN CALIBRATOR receive FDA 510(k) clearance?

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR received FDA 510(k) clearance on 1997-02-20, under 510(k) number K970396.

Who is the listed applicant for HUMAN CHORIONIC GONADOTROPIN CALIBRATOR?

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

What is the FDA product code for HUMAN CHORIONIC GONADOTROPIN CALIBRATOR?

The FDA product code for HUMAN CHORIONIC GONADOTROPIN CALIBRATOR is JIW.

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Other records listing Dade Chemistry Systems, 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.

K973650TROPONIN (TROP) METHODK973100PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORK973099PROSTATE SPECIFIC ANTIGEN CONTROLK973101PROSTATE SPECIFIC ANTIGEN METHODK971141FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEMK970387HUMAN CHORIONIC GONADOTROPIN METHOD

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Related Devices (Code: JIW)

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.

K973055WAKO CH50 LINEARITY SETWako Chemicals USA, Inc.K910255FLOW CYTOMETRY FITC/PE COMPENSATION KITSigma Diagnostics, Inc.K902575SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)Diagnostic Products Corp.K902294ACCUSCAN MICROBEAD STANDARDSSigma Chemical Co.K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORAnalytical Control Systems, Inc.K883389RAICHEM(TM) BILIRUBIN CONJUGATE STANDARDReagents Applications, 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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