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FDA 510(k)

INNOVACON HCG UKTRA TEST DEVICE

K-Number: K062361 · 2006-10-23

ApplicantInnovacon, Inc.
Decision Date2006-10-23
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INNOVACON HCG UKTRA TEST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Innovacon, Inc.. It received FDA 510(k) clearance on 2006-10-23 under 510(k) number K062361. 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 INNOVACON HCG UKTRA TEST DEVICE?

INNOVACON HCG UKTRA TEST DEVICE is a medical device that received FDA 510(k) clearance on 2006-10-23. The listed applicant is Innovacon, Inc.. The 510(k) number is K062361.

When did INNOVACON HCG UKTRA TEST DEVICE receive FDA 510(k) clearance?

INNOVACON HCG UKTRA TEST DEVICE received FDA 510(k) clearance on 2006-10-23, under 510(k) number K062361.

Who is the listed applicant for INNOVACON HCG UKTRA TEST DEVICE?

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

What is the FDA product code for INNOVACON HCG UKTRA TEST DEVICE?

The FDA product code for INNOVACON HCG UKTRA TEST DEVICE is JHI.

Related Clinical Trials

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.

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Other records listing Innovacon, 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.

K063673INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICEK061718INNOVACON SPECTRUM II TEST CARD

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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