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510(k) K842600

STREP-A-CHEK by E-Y Laboratories, Inc. — Product Code JSF

K842600 is an FDA 510(k) premarket notification submitted by E-Y Laboratories, Inc. for the device "STREP-A-CHEK". The FDA issued a decision of Substantially Equivalent on July 11, 1984. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. E-Y Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1984
Date Received
July 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by E-Y Laboratories, Inc.

  • K934130 — SWABZYME OXIDASE (September 14, 1994)
  • K940162 — GONOCHEK II REAGENT TUBES (September 9, 1994)
  • K934125 — GONOCHEK-II, MODIFICATION (September 9, 1994)
  • K940161 — B-LACTAMASE REAGENT TUBES (September 9, 1994)
  • K934129 — STREP-A-CHEK (August 26, 1994)
  • K940124 — EY-20 REAGENT TUBES (August 26, 1994)
  • K940020 — STREP-A-CHEK(TM) REAGENT STRIPS (August 26, 1994)
  • K844276 — E-COLI-CHEK TUBE (December 13, 1984)
  • K840810 — SWABZYME-OXIDASE (April 4, 1984)
  • K840884 — STREP-A-CHEK TUBE (March 23, 1984)

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (April 1, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880110 — CYSTINE TRYPTIC MEDIUM W/DEXTROSE (March 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880139 — ONPG TEST REAGENT (March 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (March 30, 1988)

FDA data resources