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FDA 510(k)

CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504

K-Number: K873788 · 1987-11-23

ApplicantPacific Biotech, Inc.
Decision Date1987-11-23
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Biotech, Inc.. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K873788. 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 CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504?

CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K873788.

When did CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 receive FDA 510(k) clearance?

CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 received FDA 510(k) clearance on 1987-11-23, under 510(k) number K873788.

Who is the listed applicant for CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504?

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

What is the FDA product code for CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504?

The FDA product code for CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 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.

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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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