AMERI CLEAR— 510(k) K832011

Substantially Equivalent

Stephens Scientific

FDA 510(k) clearance K832011 for AMERI CLEAR, Substantially Equivalent on 1983-08-12. Applicant: Stephens Scientific. Device class: 1.

Clearance details

Applicant: Stephens Scientific
Product code: Code KEM
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1983-06-23
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KEM

K881282 — XYLENE1988-04-05
K874461 — HEMO-SOL1987-12-04
K861490 — PERMACLEAR SOLUTION CAT. NO. 49501986-05-06
K855109 — CLEARENE, CLEARING AGENT1986-01-07
K853694 — XYLENE SUBSTITUTE1985-10-22

More clearances from Stephens Scientific

K893772 — TISSUE EMBEDDING MEDIUM1989-06-22
K881359 — DECALCIFYING SOLUTION II1988-04-19
K872625 — DECALCIFYING SOLUTION1987-08-06

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