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FDA 510(k)

BETA-HCG RIA

K-Number: K772039 · 1977-11-23

ApplicantMonitor Science Corp.
Decision Date1977-11-23
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETA-HCG RIA is the device name listed in this FDA 510(k) record. The listed applicant is Monitor Science Corp.. It received FDA 510(k) clearance on 1977-11-23 under 510(k) number K772039. 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 BETA-HCG RIA?

BETA-HCG RIA is a medical device that received FDA 510(k) clearance on 1977-11-23. The listed applicant is Monitor Science Corp.. The 510(k) number is K772039.

When did BETA-HCG RIA receive FDA 510(k) clearance?

BETA-HCG RIA received FDA 510(k) clearance on 1977-11-23, under 510(k) number K772039.

Who is the listed applicant for BETA-HCG RIA?

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

What is the FDA product code for BETA-HCG RIA?

The FDA product code for BETA-HCG RIA is JHI.

Other records listing Monitor Science 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.

K790580RIA KIT, PROSTATIC ACIDK780949BIO-MONITOR AMIKACINK780950BIO-MONITOR TOBRAMYCINK780951BIO-MONITOR GENTAMICINK772038KANAMYCIN RIA

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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