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FDA 510(k)

B-HCG HUMAN SERUM CONTROLS

K-Number: K932479 · 1993-12-02

ApplicantPyramid Biological Corp.
Decision Date1993-12-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

B-HCG HUMAN SERUM CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Pyramid Biological Corp.. It received FDA 510(k) clearance on 1993-12-02 under 510(k) number K932479. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-HCG HUMAN SERUM CONTROLS?

B-HCG HUMAN SERUM CONTROLS is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is Pyramid Biological Corp.. The 510(k) number is K932479.

When did B-HCG HUMAN SERUM CONTROLS receive FDA 510(k) clearance?

B-HCG HUMAN SERUM CONTROLS received FDA 510(k) clearance on 1993-12-02, under 510(k) number K932479.

Who is the listed applicant for B-HCG HUMAN SERUM CONTROLS?

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

What is the FDA product code for B-HCG HUMAN SERUM CONTROLS?

The FDA product code for B-HCG HUMAN SERUM CONTROLS is JJX.

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Other records listing Pyramid Biological 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.

K964675H.PYLORI CONTROLSK962399HEPATITIS NEGATIVE CONTROLK961317SYPHILIS IGM HUMAN SERUM CONTROLSK960493SYPHILIS IGG HUMAN SERUM CONTROLSK954515ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLAK953826ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA

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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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