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FDA 510(k)

SERUM PROTEIN CONTROLS

K-Number: K944515 · 1994-11-17

ApplicantPyramid Biological Corp.
Decision Date1994-11-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM PROTEIN 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 1994-11-17 under 510(k) number K944515. 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 SERUM PROTEIN CONTROLS?

SERUM PROTEIN CONTROLS is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Pyramid Biological Corp.. The 510(k) number is K944515.

When did SERUM PROTEIN CONTROLS receive FDA 510(k) clearance?

SERUM PROTEIN CONTROLS received FDA 510(k) clearance on 1994-11-17, under 510(k) number K944515.

Who is the listed applicant for SERUM PROTEIN 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 SERUM PROTEIN CONTROLS?

The FDA product code for SERUM PROTEIN 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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