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510(k) K010891

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 by Digene Corp. — Product Code LSK

K010891 is an FDA 510(k) premarket notification submitted by Digene Corp. for the device "MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01". The FDA issued a decision of Substantially Equivalent on September 25, 2001. The device falls under product code LSK (Dna-Reagents, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Digene Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2001
Date Received
March 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Chlamydia
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Digene Corp.

  • K010893 — MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 (September 24, 2001)
  • K010892 — MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (September 24, 2001)
  • K981567 — HYBRID CAPTURE II CT/GC TEST (February 29, 2000)
  • K981485 — HYBRID CAPTURE II GC-ID (November 29, 1999)
  • K990023 — HYBRID CAPTURE II CT-ID TEST (October 25, 1999)
  • K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAY (September 29, 1998)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K971586 — DIGENE CERVICAL BRUSH (September 19, 1997)

Other clearances for product code LSK

  • K092704 — ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8 (May 28, 2010)
  • K010892 — MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (September 24, 2001)
  • K990023 — HYBRID CAPTURE II CT-ID TEST (October 25, 1999)
  • K920302 — PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY (April 6, 1994)
  • K920378 — PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS (April 29, 1992)
  • K874878 — GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS (December 29, 1987)
  • K871878 — RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (October 28, 1987)

FDA data resources