ACID FAST KIT— 510(k) K781643

Substantially Equivalent

Bioscientific

FDA 510(k) clearance K781643 for ACID FAST KIT, Substantially Equivalent on 1978-10-03. Applicant: Bioscientific. Device class: 1.

Clearance details

Applicant: Bioscientific
Product code: Code JTS
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1978-09-25
Decision date: 1978-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL1980-07-14
K801268 — HEMOGLOBIN CONTROL LEVELS1980-07-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.