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FDA 510(k)

ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT

K-Number: K955266 · 1996-02-29

ApplicantBoehringer Mannheim Italia Spa
Decision Date1996-02-29
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Italia Spa. It received FDA 510(k) clearance on 1996-02-29 under 510(k) number K955266. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT?

ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT is a medical device that received FDA 510(k) clearance on 1996-02-29. The listed applicant is Boehringer Mannheim Italia Spa. The 510(k) number is K955266.

When did ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT receive FDA 510(k) clearance?

ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT received FDA 510(k) clearance on 1996-02-29, under 510(k) number K955266.

Who is the listed applicant for ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT?

The FDA 510(k) record lists Boehringer Mannheim Italia Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT?

The FDA product code for ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT is JHI.

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Other records listing Boehringer Mannheim Italia Spa 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.

K936013EVATEST STRIPK935502EVENT TEST STRIP HCG

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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