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FDA 510(k)

MYCOPLASMA HYORHINIS (BTS-7)

K-Number: K781390 · 1978-09-01

ApplicantFlow Laboratories, Inc.
Decision Date1978-09-01
Product CodeKPB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA HYORHINIS (BTS-7) is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1978-09-01 under 510(k) number K781390. The device is classified under product code KPB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCOPLASMA HYORHINIS (BTS-7)?

MYCOPLASMA HYORHINIS (BTS-7) is a medical device that received FDA 510(k) clearance on 1978-09-01. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K781390.

When did MYCOPLASMA HYORHINIS (BTS-7) receive FDA 510(k) clearance?

MYCOPLASMA HYORHINIS (BTS-7) received FDA 510(k) clearance on 1978-09-01, under 510(k) number K781390.

Who is the listed applicant for MYCOPLASMA HYORHINIS (BTS-7)?

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

What is the FDA product code for MYCOPLASMA HYORHINIS (BTS-7)?

The FDA product code for MYCOPLASMA HYORHINIS (BTS-7) is KPB.

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Other records listing Flow Laboratories, 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.

K861897UNISKAN IIK862066TITERTEK MICROPLATE WASHER S-12K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEK861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)K860762GAMMA-FREE HORSE SERUM

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Related Devices (Code: KPB)

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.

K781875STAIN KIT FOR CELL CULTURES (30-100-00)Flow Laboratories, Inc.K781874MYCOPLASMA ARGININI FITC (30-403-41)Flow Laboratories, Inc.K771867MYCOPLASMA DETECTION KITBioassay Systems Research Corp.

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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