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510(k) K800943

PENTEX BOVINE ALBUMIN 30% SOLUTION by Miles Laboratories, Inc. — Product Code KSG

K800943 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "PENTEX BOVINE ALBUMIN 30% SOLUTION". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code KSG (Media, Potentiating For In Vitro Diagnostic Use), a Class II device regulated under 21 CFR 864.9600. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 22, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Potentiating For In Vitro Diagnostic Use
Device Class
Class II
Regulation Number
864.9600
Review Panel
HE
Submission Type

Other clearances by Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (April 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (April 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (December 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST (February 18, 1987)

Other clearances for product code KSG

  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K812222 — EM-X (September 23, 1981)
  • K800189 — BOVINE ALBUMIN 22% & 30% SOLUTIONS (February 13, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K791113 — LOW IONIC STRENGTH SOLUTION (LISS) (June 28, 1979)
  • K790973 — LO-ION (June 15, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)
  • K790498 — LISS REAGENT (April 3, 1979)
  • K781435 — ORTHO LOW IONIC SOLUTION (September 14, 1978)
  • K781397 — EM-V (September 14, 1978)

FDA data resources