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FDA 510(k)

FREEZE DRIED PAPAIN

K-Number: K810803 · 1981-07-21

ApplicantBiological Corp. of America
Decision Date1981-07-21
Product CodeKSK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FREEZE DRIED PAPAIN is the device name listed in this FDA 510(k) record. The listed applicant is Biological Corp. of America. It received FDA 510(k) clearance on 1981-07-21 under 510(k) number K810803. The device is classified under product code KSK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREEZE DRIED PAPAIN?

FREEZE DRIED PAPAIN is a medical device that received FDA 510(k) clearance on 1981-07-21. The listed applicant is Biological Corp. of America. The 510(k) number is K810803.

When did FREEZE DRIED PAPAIN receive FDA 510(k) clearance?

FREEZE DRIED PAPAIN received FDA 510(k) clearance on 1981-07-21, under 510(k) number K810803.

Who is the listed applicant for FREEZE DRIED PAPAIN?

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

What is the FDA product code for FREEZE DRIED PAPAIN?

The FDA product code for FREEZE DRIED PAPAIN is KSK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biological Corp. of America 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.

K813404FREEZE DRIED FICINK812565ELUTION SOLUTIONK812222EM-XK781397EM-VK760162HEMATOLOGY CONTROL

Related Devices (Code: KSK)

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.

K813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONGamma Biologicals, Inc.K813404FREEZE DRIED FICINBiological Corp. of AmericaK780962AUTOMATED ENZYMEHyland Therapeutic Div., Travenol LaboratoriesK760123AUTOZYMEBd Becton Dickinson Vacutainer Systems Preanalytic

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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