Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

49 results for "Leeco Diagnostics, Inc."
1–24 of 49
Search insights Median review: 36d Cleared: 100% Top manufacturer: Leeco Diagnostics, Inc. Lead specialty: Chemistry
Cleared Oct 31, 1989
LEECO PREVIEW(R) EBV (EIA)
K895765 · KTN
Leeco Diagnostics, Inc.
Immunology · 35d
Cleared Aug 15, 1989
LEECO VIS-DISK STREP-A (EIA)
K894122 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 64d
Cleared Jun 16, 1989
VIS-DISK HCG (EIA) JPL-041M
K891096 · DHA
Leeco Diagnostics, Inc.
Chemistry · 106d
Cleared Jun 16, 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · DHA
Leeco Diagnostics, Inc.
Chemistry · 106d
Cleared Sep 13, 1988
PRL-QUANT
K883269 · CFT
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Mar 15, 1988
CONCEP-7-BHCG
K880577 · JHI
Leeco Diagnostics, Inc.
Chemistry · 34d
Cleared Feb 11, 1988
LEECO PREGNASTICK (EIA) CATALOG #003
K880069 · LCX
Leeco Diagnostics, Inc.
Chemistry · 31d
Cleared Mar 10, 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259 · JHI
Leeco Diagnostics, Inc.
Chemistry · 46d
Cleared Feb 03, 1987
LEECO VIS-CUBE STREP A (EIA)
K864170 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 102d
Cleared Jan 09, 1987
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
K863999 · LCX
Leeco Diagnostics, Inc.
Chemistry · 87d
Cleared Dec 15, 1986
VIS-CUBE HCG (EIA)
K863933 · JHI
Leeco Diagnostics, Inc.
Chemistry · 68d
Cleared Sep 16, 1986
RIGHT-DAY OVULATION HOME TEST
K861354 · CEP
Leeco Diagnostics, Inc.
Chemistry · 159d
Cleared Jul 29, 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · JHJ
Leeco Diagnostics, Inc.
Chemistry · 85d
Cleared Jul 29, 1986
RIGHT-DAY URINARY LH (EIA)
K860538 · CEP
Leeco Diagnostics, Inc.
Chemistry · 167d
Cleared Jun 13, 1986
LEE-BEAD PROLACTIN (EIA)
K861945 · CFT
Leeco Diagnostics, Inc.
Chemistry · 24d
Cleared May 13, 1986
LEECO-SCREEN, STREP A (EIA)
K860947 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 62d
Cleared Mar 17, 1986
LEECO TESTOSTERONE DIAGNOSTIC KIT
K860003 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 74d
Cleared Jan 13, 1986
LEE-BEAD BETA FSH (EIA)
K854837 · CGJ
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Jan 07, 1986
LEE-BEAD BETA LH (EIA)
K854838 · CEP
Leeco Diagnostics, Inc.
Chemistry · 35d
Cleared Oct 22, 1985
BETA-TSH-IRMA
K853977 · JLW
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG EIA
K850531 · JHI
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG IRMA
K850530 · JHI
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Mar 04, 1985
LEECO CONCEP-7-BHCG LEIAD II
K850201 · JHI
Leeco Diagnostics, Inc.
Chemistry · 45d
Cleared Feb 06, 1985
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
K850056 · JLS
Leeco Diagnostics, Inc.
Chemistry · 29d