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510(k) K842921

REES & ECKER DILUTION FLUID by E K Ind., Inc. — Product Code GLG

K842921 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "REES & ECKER DILUTION FLUID". The FDA issued a decision of Substantially Equivalent on September 7, 1984. The device falls under product code GLG (Platelet Counting, Manual), a Class I device regulated under 21 CFR 864.6160. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Platelet Counting, Manual
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type

Other clearances by E K Ind., Inc.

  • K842931 — DRABKIN REAGENT (September 21, 1984)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)
  • K842731 — FORMALIN-ACETO-ALCOHOL FIXATIVE (September 11, 1984)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

Other clearances for product code GLG

  • K811084 — LABTRONIX PLATELET COUNTER(L/O/C.) (July 23, 1981)
  • K772105 — PLATELET KIT (November 30, 1977)

FDA data resources