MICROSCAN(R) RAPID FLUOROGENIC PANELS
FDA premarket approval P870049/S030 · decided 2000-06-05
Approval details
- PMA number
- P870049
- Supplement
- S030
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MICROSCAN(R) RAPID FLUOROGENIC PANELS
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Applicant
- Dade Intl., Inc.
- Date received
- 2000-05-17
- Decision date
- 2000-06-05
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LON
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- West Sacramento, CA
- Statement
- APPROVAL FOR LABELING CHANGE THAT ADDS A CONTRAINDICATION TO THE GRAM NEGATIVE MICROSCAN RAPID FLUOROGENIC PANELS OF "DO NOT REPORT" WHEN TESTING ALL GRAM NEGATIVE ORGANISMS WITH CEFOPERAZONE USING EITHER THE MIC OR BREAKPOINT FORMATS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DADE INNOVIN (K974343) | Dade Intl., Inc. | 1998-07-22 |
| DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ (K970505) | Dade Intl., Inc. | 1997-11-17 |
| DADE TRU-LIQUID CARDIAC CONTROL (K973974) | Dade Intl., Inc. | 1997-11-06 |
| CARDIAC TROPONIN-I (TROP) CALIBRATOR (K973668) | Dade Intl., Inc. | 1997-10-20 |
| DRIED GRAM-POSITIVE MIC/COMBO PANELS (K972524) | Dade Intl., Inc. | 1997-09-08 |
| DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K972782) | Dade Intl., Inc. | 1997-08-15 |
| DADE TRU-LIQUID BILIRUBIN CONTROL (K972287) | Dade Intl., Inc. | 1997-07-07 |
| PARAMAX CHOLESTEROL REAGENT (K964660) | Dade Intl., Inc. | 1997-06-04 |