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510(k) K832011

AMERI CLEAR by Stephens Scientific — Product Code KEM

K832011 is an FDA 510(k) premarket notification submitted by Stephens Scientific for the device "AMERI CLEAR". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code KEM (Agent, Clearing), a Class I device regulated under 21 CFR 864.4010. Stephens Scientific has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
June 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Clearing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Stephens Scientific

  • K893772 — TISSUE EMBEDDING MEDIUM (June 22, 1989)
  • K881359 — DECALCIFYING SOLUTION II (April 19, 1988)
  • K872625 — DECALCIFYING SOLUTION (August 6, 1987)

Other clearances for product code KEM

  • K881282 — XYLENE (April 5, 1988)
  • K874461 — HEMO-SOL (December 4, 1987)
  • K861490 — PERMACLEAR SOLUTION CAT. NO. 4950 (May 6, 1986)
  • K855109 — CLEARENE, CLEARING AGENT (January 7, 1986)
  • K853694 — XYLENE SUBSTITUTE (October 22, 1985)
  • K854083 — XYLENE SUBSTITUTE MONTANT (October 22, 1985)
  • K842861 — PRO-PAR CLEARANT (August 21, 1984)
  • K842721 — LIMONENE (August 3, 1984)
  • K832451 — CLEAR-RITE 3 (August 12, 1983)
  • K830627 — CLARIFIER-RICHARD-ALLAN (March 24, 1983)

FDA data resources