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FDA 510(k)

ACON COMBO PREGNANCY

K-Number: K993065 · 1999-10-08

ApplicantACON Laboratories, Inc.
Decision Date1999-10-08
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACON COMBO PREGNANCY is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 1999-10-08 under 510(k) number K993065. 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 ACON COMBO PREGNANCY?

ACON COMBO PREGNANCY is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K993065.

When did ACON COMBO PREGNANCY receive FDA 510(k) clearance?

ACON COMBO PREGNANCY received FDA 510(k) clearance on 1999-10-08, under 510(k) number K993065.

Who is the listed applicant for ACON COMBO PREGNANCY?

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

What is the FDA product code for ACON COMBO PREGNANCY?

The FDA product code for ACON COMBO PREGNANCY is JHI.

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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

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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