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FDA 510(k)

AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT

K-Number: K881355 · 1988-06-08

ApplicantAmersham Corp.
Decision Date1988-06-08
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1988-06-08 under 510(k) number K881355. 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 AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT?

AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT is a medical device that received FDA 510(k) clearance on 1988-06-08. The listed applicant is Amersham Corp.. The 510(k) number is K881355.

When did AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT receive FDA 510(k) clearance?

AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT received FDA 510(k) clearance on 1988-06-08, under 510(k) number K881355.

Who is the listed applicant for AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT?

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

What is the FDA product code for AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT?

The FDA product code for AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT is JHI.

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Other records listing Amersham Corp. 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

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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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