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510(k) K870651

BIGGY AGAR by Hardy Media — Product Code JSH

K870651 is an FDA 510(k) premarket notification submitted by Hardy Media for the device "BIGGY AGAR". The FDA issued a decision of Substantially Equivalent on April 14, 1987. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Hardy Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1987
Date Received
February 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Hardy Media

  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880124 — LOWENSTEIN-JENSEN, W/NACL (March 31, 1988)
  • K880123 — LOWENSTEIN-JENSEN SLANT (March 31, 1988)
  • K880133 — MIL MEDIUM (March 31, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880125 — LOWENSTEIN-JENSEN, SELECTIVE (March 31, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)

Other clearances for product code JSH

  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources