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FDA 510(k)

CONTROLCHEK II(TM)

K-Number: K873034 · 1987-08-19

ApplicantPetra Biomedical Products, Inc.
Decision Date1987-08-19
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CONTROLCHEK II(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Petra Biomedical Products, Inc.. It received FDA 510(k) clearance on 1987-08-19 under 510(k) number K873034. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROLCHEK II(TM)?

CONTROLCHEK II(TM) is a medical device that received FDA 510(k) clearance on 1987-08-19. The listed applicant is Petra Biomedical Products, Inc.. The 510(k) number is K873034.

When did CONTROLCHEK II(TM) receive FDA 510(k) clearance?

CONTROLCHEK II(TM) received FDA 510(k) clearance on 1987-08-19, under 510(k) number K873034.

Who is the listed applicant for CONTROLCHEK II(TM)?

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

What is the FDA product code for CONTROLCHEK II(TM)?

The FDA product code for CONTROLCHEK II(TM) is JTO.

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.

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Other records listing Petra Biomedical Products, Inc. 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.

K871445CONTROLCHEK(TM)K833613FLUOR-B MEL A DIRECT FLUORESCENT ANTIK833612FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI

Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.

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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