MICROSCAN RAPID FLUOROGENIC PANELS
FDA premarket approval P870049/S028 · decided 1999-01-25
Approval details
- PMA number
- P870049
- Supplement
- S028
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MICROSCAN RAPID FLUOROGENIC PANELS
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Applicant
- Dade Intl., Inc.
- Date received
- 1999-01-04
- Decision date
- 1999-01-25
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LON
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- West Sacramento, CA
- Statement
- Approval for the addition of a limitation to use an alternative method for testing of Proteus mirabilis and Enterobacter spp. with the antibiotic Cefazolin in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |