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510(k) K890333

ALBUMIN REAGENT by Alpkem Corp. — Product Code EIX

K890333 is an FDA 510(k) premarket notification submitted by Alpkem Corp. for the device "ALBUMIN REAGENT". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code EIX (Probe, Periodontic), a Class I device regulated under 21 CFR 872.4565. Alpkem Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Periodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Alpkem Corp.

  • K894011 — TOTAL GALACTOSE (January 11, 1990)
  • K891070 — PHENYLALANINE (NINHYDRIN REACTION) (October 27, 1989)
  • K890334 — TOTAL CHOLESTEROL REAGENT (May 3, 1989)
  • K890337 — TRIGLYCERIDES - GPO REAGENT (March 9, 1989)
  • K890336 — GLUCOSE (GOD) REAGENT (February 27, 1989)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (February 17, 1989)
  • K883020 — RFA-300 RAPID FLOW ANALYZER W/COMPUTER (September 2, 1988)
  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)
  • K852005 — MG REAGENT (June 25, 1985)

Other clearances for product code EIX

  • K960245 — VIP VICTOR INTERACTIVE PROBE (April 4, 1996)
  • K944848 — THE VIVACARE T.P.S. PROBE (December 14, 1994)
  • K936221 — PROBE TIP/PERI PROBE/PERI PROBE COMP. (August 1, 1994)
  • K880827 — ACCUTEK PERIODONTAL PROBE (April 12, 1988)
  • K875076 — FLORIDA PROBE (March 10, 1988)
  • K870280 — ACCUDENT ACCUPROBE (June 8, 1987)
  • K871504 — DISPOSABLE PERIODONTAL PROBE (May 6, 1987)
  • K823324 — DENTAL INSTRUMENTS - PROBES (November 24, 1982)

FDA data resources