Atlas FDA

IMX PAP

FDA 510(k) clearance K925377 · decided 1993-01-13

Clearance details

K-number
K925377
Device name
IMX PAP
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1992-10-23
Decision date
1993-01-13
Days to decision
82 days
Clearance type
Traditional
Product code
JFH
Device class
2
Regulation number
862.1020
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 (K000257)Diagnostic Products Corp.2000-02-23
UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (K981573)United Biotech, Inc.1998-09-15
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT (K964756)Wano-Tech Corp.1997-04-23
IMMULITE PAP (K931701)Diagnostic Products Corp.1994-01-27
HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (K921745)Hybritech, Inc.1992-07-30
MILENIA PAP IRMA CATALOG #: MKPA1, X (K902937)Diagnostic Products Corp.1990-09-21
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 (K901933)Diagnostic Products Corp.1990-06-28
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) (K895723)Diagnostic Products Corp.1989-10-31
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI (K893508)Baxter Healthcare Corp1989-08-04
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) (K884748)Technicon Instruments Corp.1989-01-30
ABBOTT PAP-EIA (K873903)Abbott Laboratories1987-12-01
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY (K864945)Hybritech, Inc.1987-01-05

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30