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510(k) K801980

SPOR-TEST CULTURE MEDIA by Mdt Corp., Inc. — Product Code JSG

K801980 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "SPOR-TEST CULTURE MEDIA". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Mdt Corp., Inc.

  • K960777 — MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR (May 23, 1996)
  • K942485 — MDT UROLOGY TABLE (August 26, 1994)
  • K942486 — IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE (August 10, 1994)
  • K924380 — MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE (February 16, 1994)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K924955 — MDT/HARVEY MC-8 AND MC-10 (October 15, 1993)
  • K932094 — BOVIE ULTRASONIC SURGICAL ASPIRATOR (July 21, 1993)
  • K931169 — MDT DENTAL CHAIR (May 20, 1993)
  • K920930 — MDT/CASTLE 10/90 DUAL LOAD STATION (March 31, 1993)
  • K922212 — MDT CASTLE BIOSIGN TEST PACK (August 10, 1992)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)

FDA data resources