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

38 results for "Marion Laboratories, Inc."
1–24 of 38
Search insights Median review: 44d Cleared: 100% Top manufacturer: Marion Laboratories, Inc. Lead specialty: Microbiology
Cleared Mar 23, 1989
POLYMER ADHESIVE BANDAGE
K883391 · NAD
Marion Laboratories, Inc.
General & Plastic Surgery · 226d
Cleared Jul 05, 1988
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · DKE
Marion Laboratories, Inc.
Toxicology · 201d
Cleared May 27, 1988
MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM
K875181
Marion Laboratories, Inc.
Toxicology · 162d
Cleared Mar 11, 1988
ENVICLUSIVE (TM)
K874554 · NAD
Marion Laboratories, Inc.
General & Plastic Surgery · 128d
Cleared Jan 22, 1988
ENVISAN PAD
K874552 · KOZ
Marion Laboratories, Inc.
General & Plastic Surgery · 79d
Cleared Jan 22, 1988
ENVINET(TM)
K874551 · EFQ
Marion Laboratories, Inc.
General & Plastic Surgery · 79d
Cleared Dec 18, 1987
ENVISAN PASTE
K874553 · KOZ
Marion Laboratories, Inc.
General & Plastic Surgery · 44d
Cleared Apr 14, 1987
CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST
K870864 · LLH
Marion Laboratories, Inc.
Microbiology · 42d
Cleared Sep 17, 1986
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
K863485 · LLH
Marion Laboratories, Inc.
Microbiology · 8d
Cleared Jun 16, 1986
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
K862123 · KZJ
Marion Laboratories, Inc.
Microbiology · 13d
Cleared Aug 01, 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073 · GTZ
Marion Laboratories, Inc.
Microbiology · 9d
Cleared Jul 19, 1985
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
K852044 · LLH
Marion Laboratories, Inc.
Microbiology · 71d
Cleared Jun 04, 1985
BAC-T-SCREEN
K851399 · JXA
Marion Laboratories, Inc.
Microbiology · 56d
Cleared Mar 05, 1985
BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE
K845008 · KZJ
Marion Laboratories, Inc.
Microbiology · 69d
Cleared Jan 13, 1984
BAC-T-SCREEN
K833917 · JTA
Marion Laboratories, Inc.
Chemistry · 60d
Cleared Jun 30, 1983
TOXI-LAB CANNABINOID THC SCREEN
K831456 · DKE
Marion Laboratories, Inc.
Toxicology · 55d
Cleared Apr 08, 1983
ARTIMICROBIAL REMOVAL DEVICE
K830372 · LJF
Marion Laboratories, Inc.
Microbiology · 63d
Cleared Mar 01, 1983
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850 · JXA
Marion Laboratories, Inc.
Microbiology · 70d
Cleared Jan 14, 1983
TOXI-LAB RAPID SCREEN
K823523 · DKJ
Marion Laboratories, Inc.
Toxicology · 46d
Cleared Aug 25, 1982
ANTIMICROBIAL REMOVAL DEVICE (ARD)
K822344 · LJF
Marion Laboratories, Inc.
Microbiology · 20d
Cleared Nov 02, 1981
MULTI-GRAM DEVELOPING TANK R-12 & R-3
K812919 · DKK
Marion Laboratories, Inc.
Toxicology · 14d
Cleared Apr 29, 1981
BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M
K811067 · KZT
Marion Laboratories, Inc.
Microbiology · 12d
Cleared Apr 03, 1981
ANTIMICROBIAL REMOVAL DEVICE
K810613 · MDB
Marion Laboratories, Inc.
Microbiology · 28d
Cleared Jan 12, 1981
MINI-TIP CULTURETTE
K803298 · JTW
Marion Laboratories, Inc.
Microbiology · 13d