Home / 510(k) Clearances / K781506

510(k) K781506

MIC-BIO-PLATE by Pasco Laboratories, Inc. — Product Code JSF

K781506 is an FDA 510(k) premarket notification submitted by Pasco Laboratories, Inc. for the device "MIC-BIO-PLATE". The FDA issued a decision of Substantially Equivalent on Oct 17, 1978. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Pasco Laboratories, Inc. has 65 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 17, 1978
Date Received
Jul 25, 1978
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
510(k) Exempt

Other clearances by Pasco Laboratories, Inc.

  • K042331 — PASCO MIC AND MIC/ID PANELS (Oct 7, 2004)
  • K041776 — PASCO MIC AND MIC/ID PANELS (Aug 3, 2004)
  • K041214 — PASCO MIC AND MIC/ID PANELS (Jun 7, 2004)
  • K033119 — PASCO MIC AND MIC/ID PANELS (Nov 18, 2003)
  • K031727 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (Jul 30, 2003)
  • K031205 — PASCO MIC AND MIC/ID PANELS (Jun 13, 2003)
  • K031103 — PASCO MIC AND MIC/ID PANELS (ERTAPENEM) (Jun 12, 2003)
  • K030933 — PASCO MIC AND MIC/ID PANELS (May 1, 2003)
  • K030620 — PASCO MIC AND MIC/ID PANELS (Apr 14, 2003)
  • K020331 — PASCO MIC AND MIC/ID PANELS (Mar 20, 2002)

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (Apr 1, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (Mar 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (Mar 31, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (Mar 31, 1988)
  • K880118 — MOELLOERS DECARBOXYLASE, ARGININE (Mar 30, 1988)
  • K880110 — CYSTINE TRYPTIC MEDIUM W/DEXTROSE (Mar 30, 1988)
  • K880135 — NITRATE BROTH (Mar 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (Mar 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (Mar 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (Mar 30, 1988)

FDA data resources

Source: FDA 510(k) database entry for K781506. Report a data issue: hello@regdatalab.com.