FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

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