Atlas FDA

PREP TYPE A EXTRACTION CARTRIDGE

FDA 510(k) clearance K823697 · decided 1983-01-05

Clearance details

K-number
K823697
Device name
PREP TYPE A EXTRACTION CARTRIDGE
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Decision
Substantially Equivalent
Date received
1982-12-09
Decision date
1983-01-05
Days to decision
27 days
Clearance type
Traditional
Product code
DJY
Device class
1
Regulation number
862.2230
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch E.I. Dupont DE Nemours & Co.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
THE CDI(R) SYSTEM 400 (K890113)Cardiovascular Devices, Inc.1989-05-23
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (K883615)Supelco, Inc.1988-12-16
SOLID PHASE EXTRACTION TUBES (K881361)Supelco, Inc.1988-08-08
DUPONT PREP TYPE SI EXTRACITON CARTRIDGE (K850963)E.I. Dupont DE Nemours & Co., Inc.1985-03-25
TRISACRYL GF 05 & TRISACRYL GF 2000 (K840985)Lkb Instruments, Inc.1984-04-19
HC40/HC75 PREPACKED COLUMS (K832198)Hamilton Co.1983-08-12
PREFILLED IEC COLUMNS (K831289)Berwick Medical Products, Inc.1983-06-16
DUPONT PREP TYPE AS EXTRACTION CARTRIDE (K830693)E.I. Dupont DE Nemours & Co., Inc.1983-04-05
DUPONT PREP OD EXTRACTION CARTRIDE (K830692)E.I. Dupont DE Nemours & Co., Inc.1983-04-05
BOND ELUT COLUMNS (K800061)Analytichem International, Inc.1980-03-12

Recalls involving this device

No recalls on record reference this clearance.