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510(k) K770508

SMAC SYSTEM by Mid Tech, Inc. — Product Code JCC

K770508 is an FDA 510(k) premarket notification submitted by Mid Tech, Inc. for the device "SMAC SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 1977. The device falls under product code JCC (Ph Buffer), a Class I device regulated under 21 CFR 864.4010. Mid Tech, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1977
Date Received
March 17, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Buffer
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Mid Tech, Inc.

  • K810951 — REAGENTS FOR QUANT. ENZYMATIC DETER.-TR. (April 23, 1981)
  • K791869 — GLUCOSE OXIDASE (FRINDER) KIT (October 1, 1979)
  • K791313 — ARS, CHEMISTRY (August 16, 1979)
  • K771033 — SMAC SYS., SUPPLEMENTAL PRODUCTS FOR (August 4, 1977)

Other clearances for product code JCC

  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842914 — WRIGHT STAIN BUFFER (September 7, 1984)
  • K841423 — SCOTTS TAP WATER SUBSTITUTE 7 (May 22, 1984)
  • K811791 — PHOSPHATE BUFFERED SALINE (1X) (August 25, 1981)
  • K811251 — CITRATE BUFFER (May 21, 1981)
  • K792574 — MOPSO BUFFER (January 21, 1980)

FDA data resources