Atlas FDA

ANTITUBERCULOUS DRUGS (SIRE)

FDA 510(k) clearance K822329 · decided 1982-09-02

Clearance details

K-number
K822329
Device name
ANTITUBERCULOUS DRUGS (SIRE)
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1982-08-03
Decision date
1982-09-02
Days to decision
30 days
Clearance type
Traditional
Product code
JTT
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN (K983310)Accumed Intl., Inc.1998-12-17
PASCO MIC AND MIC/ID PANELS (K935805)Pasco Laboratories, Inc.1994-06-13
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST (K895362)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-01
MODIFIED IMIPENEM SUSCEPTIBILITY POWDER (K880574)Merck, Sharp & Dohme1988-05-04
CIPRO (TM) DIAGNOSTIC POWDER (K872081)Miles Pharmaceuticals1987-06-15
NORFLOXACIN SUSCEPTIBILITY POWDER (K864442)Merck, Sharp & Dohme1986-12-11
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK (K860031)Organon Teknika Corp.1986-03-06
IMIPENEM SUSCEPTIBILITY POWDER (K855071)Merck, Sharp & Dohme1986-03-06
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 (K855106)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-03-06
IMIPENEM 10 MCG SENSITIVITY DISCS (K855207)Difco Laboratories, Inc.1986-03-06
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (K830758)Miles Laboratories, Inc.1983-05-25
MOXALACTAM (K822866)Lilly Research Laboratories1982-12-28

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05