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510(k) K882101

HEMOGLOBIN SCREENING DEVICE by Portable Medical Laboratories, Inc. — Product Code KSL

K882101 is an FDA 510(k) premarket notification submitted by Portable Medical Laboratories, Inc. for the device "HEMOGLOBIN SCREENING DEVICE". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code KSL (Solution, Copper Sulfate For Specific Gravity Determinations), a Class I device regulated under 21 CFR 864.9320. Portable Medical Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1988
Date Received
May 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Copper Sulfate For Specific Gravity Determinations
Device Class
Class I
Regulation Number
864.9320
Review Panel
HE
Submission Type

Other clearances by Portable Medical Laboratories, Inc.

  • K874190 — CELL COUNTING GRID GRATICULE (January 5, 1988)
  • K871671 — URINOSCOPY FUNNEL (May 20, 1987)
  • K864049 — MCARTHUR MICROSCOPE, STANDARD METAL VERSION (October 29, 1986)
  • K854735 — MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (December 10, 1985)
  • K844476 — PORTABLE DIAGNOSTIC LABORATORY (March 13, 1985)
  • K844475 — SPECIMEN COLLECTION & TRANSPORT SYSTEM (February 6, 1985)
  • K844442 — RAPID DIAGNOSTIC KIT (February 1, 1985)
  • K844473 — HAND-HELD SLIDE READER (January 4, 1985)

Other clearances for product code KSL

  • K803095 — COPPER SULFATE SOLUTION SP. GR.1.055 (March 6, 1981)

FDA data resources