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510(k) K871187

LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 by In Vitro Diagnostics, Inc. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1987
Date Received
March 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by In Vitro Diagnostics, Inc.

  • K896867 — THYROID STIMULATING HORMONE-EIA-XT (February 23, 1990)
  • K896863 — DIGOXIN-EIA-XT (February 13, 1990)
  • K896866 — LUTEINIZING HORMONE-EIA-XT (February 13, 1990)
  • K896865 — VITRO T4-EIA-XT (January 30, 1990)
  • K896925 — T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT (January 18, 1990)
  • K896864 — FOLLICLE STIMULATING HORMONE-EIA-XT (January 11, 1990)
  • K873832 — REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (November 23, 1987)
  • K871188 — LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 (May 28, 1987)
  • K871183 — FLAME PHOTOMETER STANDARD #60082 140 NA/5K (May 28, 1987)
  • K871186 — CESIUM DILUENT 1.5 MMOL CS/L #60087 (May 28, 1987)

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