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510(k) K983503

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 by Boehringer Mannheim Corp. — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1998
Date Received
October 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device Class
Class I
Regulation Number
862.1580
Review Panel
CH
Submission Type

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  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K983510 — CHEMSTRIP 101 URINE ANALYZER (October 27, 1998)
  • K982948 — ELECSYS PSA, MODEL # ELECSYS 1010 (October 27, 1998)

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