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510(k) K822898

DSL 1600 by Diagnostic Systems Laboratories, Inc. — Product Code CIA

K822898 is an FDA 510(k) premarket notification submitted by Diagnostic Systems Laboratories, Inc. for the device "DSL 1600". The FDA issued a decision of Substantially Equivalent on December 9, 1982. The device falls under product code CIA (Methylthymol Blue, Calcium), a Class II device regulated under 21 CFR 862.1145. Diagnostic Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1982
Date Received
September 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methylthymol Blue, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Diagnostic Systems Laboratories, Inc.

  • K061758 — ACTIVE RENIN IRMA (July 28, 2006)
  • K020945 — AXSYM INTACT PTH, MODEL 2G06 (May 31, 2002)
  • K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 (March 1, 2002)
  • K002128 — ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (December 5, 2000)
  • K001086 — FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (May 18, 2000)
  • K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (June 21, 1999)
  • K981871 — C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (November 9, 1998)
  • K973243 — ACTIVE PSA ELISA (DSL-10-9700) (August 3, 1998)
  • K973244 — ACTIVE PSA IRMA (DSL-9700) (August 3, 1998)
  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)

Other clearances for product code CIA

  • K870369 — CALCIUM REAGENT-METHYL THYMOL BLUE METHOD (August 19, 1987)
  • K863059 — CALCIOMETER (September 26, 1986)
  • K792396 — ELVI CALCIUM (December 6, 1979)
  • K771468 — MULTISTAT III CALCIUM TEST (September 12, 1977)

FDA data resources